scholarly journals Lifestyle Intervention Enabled by Mobile Technology on Weight Loss in Patients With Nonalcoholic Fatty Liver Disease: Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Su Lin Lim ◽  
Jolyn Johal ◽  
Kai Wen Ong ◽  
Chad Yixian Han ◽  
Yiong Huak Chan ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Weight Loss ◽  
Fatty Liver ◽  
Lifestyle Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Mobile App ◽  
Control Group ◽  
Nonalcoholic Fatty Liver ◽  
Randomized Controlled

BACKGROUND The prevalence of nonalcoholic fatty liver disease (NAFLD) reaches up to 30% in the Asian adult population, with a higher prevalence in obese patients. Weight reduction is typically recommended for patients at high risk or diagnosed with NAFLD, but is a challenge to achieve. OBJECTIVE We aimed to evaluate the effect of a lifestyle intervention with a mobile app on weight loss in NAFLD patients. METHODS This prospective randomized controlled trial included 108 adults with NAFLD confirmed by steatosis on ultrasound and a body mass index ≥23 kg/m<sup>2</sup> who were recruited from a fatty liver outpatient clinic. The patients were randomly allocated to either a control group (n=53) receiving standard care, consisting of dietary and lifestyle advice by a trained nurse, or an intervention group (n=55) utilizing the Nutritionist Buddy (nBuddy) mobile app in addition to receiving dietary and lifestyle advice by a dietitian. Body weight, alanine aminotransferase (ALT), aspartate aminotransferase (AST), waist circumference, and blood pressure were measured at baseline, and then at 3 and 6 months. Intention-to-treat and per-protocol analyses were used for statistical comparisons. RESULTS The intervention group had a 5-fold higher likelihood (relative risk 5.2, <i>P</i>=.003, 95% CI 1.8-15.4) of achieving ≥5% weight loss compared to the control group at 6 months. The intervention group also showed greater reductions in weight (mean 3.2, SD 4.1 kg vs mean 0.5, SD 2.9 kg; <i>P</i>&lt;.001), waist circumference (mean 2.9, SD 5.0 cm vs mean –0.7, SD 4.4 cm; <i>P</i>&lt;.001), systolic blood pressure (mean 12.4, SD 14.8 mmHg vs mean 2.4, SD 12.4 mmHg; <i>P</i>=.003), diastolic blood pressure (mean 6.8, SD 8.9 mmHg vs mean –0.9, SD 10.0 mmHg; <i>P</i>=.001), ALT (mean 33.5, SD 40.4 IU/L vs mean 11.5, SD 35.2 IU/L; <i>P</i>=.004), and AST (mean 17.4, SD 27.5 U/L vs mean 7.4, SD 17.6 IU/L, <i>P</i>=.03) at 6 months. CONCLUSIONS Lifestyle intervention enabled by a mobile app can be effective in improving anthropometric indices and liver enzymes in patients with NAFLD. This treatment modality has the potential to be extended to a larger population scale. CLINICALTRIAL Australian New Zealand Clinical Trials Registry ACTRN12617001001381; https://tinyurl.com/w9xnfmp

scholarly journals Lifestyle Intervention Enabled by Mobile Technology on Weight Loss in Patients With Nonalcoholic Fatty Liver Disease: Randomized Controlled Trial

10.2196/14802 ◽  
2020 ◽  
Vol 8 (4) ◽  
pp. e14802
Author(s):  
Su Lin Lim ◽  
Jolyn Johal ◽  
Kai Wen Ong ◽  
Chad Yixian Han ◽  
Yiong Huak Chan ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Weight Loss ◽  
Fatty Liver ◽  
Lifestyle Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Mobile App ◽  
Control Group ◽  
Nonalcoholic Fatty Liver ◽  
Randomized Controlled

Background The prevalence of nonalcoholic fatty liver disease (NAFLD) reaches up to 30% in the Asian adult population, with a higher prevalence in obese patients. Weight reduction is typically recommended for patients at high risk or diagnosed with NAFLD, but is a challenge to achieve. Objective We aimed to evaluate the effect of a lifestyle intervention with a mobile app on weight loss in NAFLD patients. Methods This prospective randomized controlled trial included 108 adults with NAFLD confirmed by steatosis on ultrasound and a body mass index ≥23 kg/m2 who were recruited from a fatty liver outpatient clinic. The patients were randomly allocated to either a control group (n=53) receiving standard care, consisting of dietary and lifestyle advice by a trained nurse, or an intervention group (n=55) utilizing the Nutritionist Buddy (nBuddy) mobile app in addition to receiving dietary and lifestyle advice by a dietitian. Body weight, alanine aminotransferase (ALT), aspartate aminotransferase (AST), waist circumference, and blood pressure were measured at baseline, and then at 3 and 6 months. Intention-to-treat and per-protocol analyses were used for statistical comparisons. Results The intervention group had a 5-fold higher likelihood (relative risk 5.2, P=.003, 95% CI 1.8-15.4) of achieving ≥5% weight loss compared to the control group at 6 months. The intervention group also showed greater reductions in weight (mean 3.2, SD 4.1 kg vs mean 0.5, SD 2.9 kg; P<.001), waist circumference (mean 2.9, SD 5.0 cm vs mean –0.7, SD 4.4 cm; P<.001), systolic blood pressure (mean 12.4, SD 14.8 mmHg vs mean 2.4, SD 12.4 mmHg; P=.003), diastolic blood pressure (mean 6.8, SD 8.9 mmHg vs mean –0.9, SD 10.0 mmHg; P=.001), ALT (mean 33.5, SD 40.4 IU/L vs mean 11.5, SD 35.2 IU/L; P=.004), and AST (mean 17.4, SD 27.5 U/L vs mean 7.4, SD 17.6 IU/L, P=.03) at 6 months. Conclusions Lifestyle intervention enabled by a mobile app can be effective in improving anthropometric indices and liver enzymes in patients with NAFLD. This treatment modality has the potential to be extended to a larger population scale. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12617001001381; https://tinyurl.com/w9xnfmp

scholarly journals A Mobile App Lifestyle Intervention to Improve Healthy Nutrition in Women Before and During Early Pregnancy: Single-Center Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Matthijs R van Dijk ◽  
Maria P H Koster ◽  
Elsje C Oostingh ◽  
Sten P Willemsen ◽  
Eric A P Steegers ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Lifestyle Intervention ◽  
Early Pregnancy ◽  
Vegetable Intake ◽  
Controlled Trial ◽  
Intervention Group ◽  
Mobile App ◽  
Noncommunicable Diseases ◽  
Control Group ◽  
Randomized Controlled

BACKGROUND Unhealthy nutrition contributes to the worldwide rising prevalence of noncommunicable diseases. As most adverse reproductive outcomes originate during the periconception period, effective interventions targeting this period are needed. Therefore, we developed the lifestyle intervention Smarter Pregnancy to empower women to adapt a healthy diet prior to conception and during early pregnancy and performed a randomized controlled trial. OBJECTIVE The objectives of this trial were to investigate compliance and effectiveness in women using the Smarter Pregnancy program. METHODS Women aged between 18 and 45 years who were contemplating pregnancy or &lt;13 weeks pregnant and their male partners living in the urban area of Rotterdam, the Netherlands, were eligible for participation. After baseline screening, the intervention group received personal online coaching based on identified inadequate intakes of vegetables, fruits, and folic acid supplements. The sum of these risk factors was used as a dietary risk score (DRS), ranging from 0 (healthy) to 9 (unhealthy). The control group did not receive coaching. We applied an intention-to-treat principle and used a multivariable linear regression model to evaluate the change in DRS after 24 weeks. Compliance was defined as the percentage of women who completed the screening questionnaire at 24 weeks. RESULTS Of women recruited, 81.2% (177/218) completed the program (intervention: 91/218, 83.5%; control: 86/218, 78.9%; <i>P</i>=.95). After 24 weeks, the reduction in DRS of women in the intervention group was significantly larger than in the control group (β=.75, 95% CI 0.18-1.34). This reduction was mainly due to increased vegetable intake (β=.55, 95% CI 0.25-0.86). CONCLUSIONS The high compliance and the larger improvements in nutritional behaviors, especially vegetable intake, in women in the intervention group emphasizes the effectiveness of empowering women by using the lifestyle change intervention Smarter Pregnancy. CLINICALTRIAL Netherlands Trial Register: NL3927; https://www.trialregister.nl/trial/3927 INTERNATIONAL REGISTERED REPORT RR2-10.1186/s12884-017-1228-5

scholarly journals A Mobile App Lifestyle Intervention to Improve Healthy Nutrition in Women Before and During Early Pregnancy: Single-Center Randomized Controlled Trial

10.2196/15773 ◽  
2020 ◽  
Vol 22 (5) ◽  
pp. e15773 ◽  
Author(s):  
Matthijs R van Dijk ◽  
Maria P H Koster ◽  
Elsje C Oostingh ◽  
Sten P Willemsen ◽  
Eric A P Steegers ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Lifestyle Intervention ◽  
Early Pregnancy ◽  
Vegetable Intake ◽  
Controlled Trial ◽  
Intervention Group ◽  
Mobile App ◽  
Noncommunicable Diseases ◽  
Control Group ◽  
Randomized Controlled

Background Unhealthy nutrition contributes to the worldwide rising prevalence of noncommunicable diseases. As most adverse reproductive outcomes originate during the periconception period, effective interventions targeting this period are needed. Therefore, we developed the lifestyle intervention Smarter Pregnancy to empower women to adapt a healthy diet prior to conception and during early pregnancy and performed a randomized controlled trial. Objective The objectives of this trial were to investigate compliance and effectiveness in women using the Smarter Pregnancy program. Methods Women aged between 18 and 45 years who were contemplating pregnancy or <13 weeks pregnant and their male partners living in the urban area of Rotterdam, the Netherlands, were eligible for participation. After baseline screening, the intervention group received personal online coaching based on identified inadequate intakes of vegetables, fruits, and folic acid supplements. The sum of these risk factors was used as a dietary risk score (DRS), ranging from 0 (healthy) to 9 (unhealthy). The control group did not receive coaching. We applied an intention-to-treat principle and used a multivariable linear regression model to evaluate the change in DRS after 24 weeks. Compliance was defined as the percentage of women who completed the screening questionnaire at 24 weeks. Results Of women recruited, 81.2% (177/218) completed the program (intervention: 91/218, 83.5%; control: 86/218, 78.9%; P=.95). After 24 weeks, the reduction in DRS of women in the intervention group was significantly larger than in the control group (β=.75, 95% CI 0.18-1.34). This reduction was mainly due to increased vegetable intake (β=.55, 95% CI 0.25-0.86). Conclusions The high compliance and the larger improvements in nutritional behaviors, especially vegetable intake, in women in the intervention group emphasizes the effectiveness of empowering women by using the lifestyle change intervention Smarter Pregnancy. Trial Registration Netherlands Trial Register: NL3927; https://www.trialregister.nl/trial/3927 International Registered Report Identifier (IRRID) RR2-10.1186/s12884-017-1228-5

Abstract WP419: Secondary Prevention Of Cardiovascular Events With Lifestyle Intervention In Patients With Mild Ischemic Stroke - A Randomized Controlled Trial -

Stroke ◽  
2013 ◽  
Vol 44 (suppl_1) ◽  
Author(s):  
Sumio Yamada ◽  
Yuji Kono ◽  
Kotaro Iwatsu ◽  
Hisako Okumura ◽  
Junko Yamaguchi ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Lifestyle Intervention ◽  
Lifestyle Modification ◽  
Controlled Trial ◽  
Intervention Group ◽  
Stroke Recurrence ◽  
Control Group ◽  
Vascular Events ◽  
Randomized Controlled ◽  
New Onset

Introduction: Lifestyle modification is associated with a substantially decreased risk of cardiovascular events. However, the role of lifestyle intervention for the secondary prevention in patients with ischemic stroke (IS) is inadequately defined. We assessed the hypothesis that lifestyle intervention which comprised exercise, salt reduction and nutrition advice could reduce new onset of vascular events in patients with mild IS. Methods: We conducted a single-blind randomized controlled trial that enrolled 66 patients (45 men, 21 women; mean age, 63.5 yo) with acute mild ischemic stroke. The patients were randomly allocated to a lifestyle intervention group (n = 33) or control group (n = 33). We performed lifestyle interventions, which comprised exercise training, salt restriction and nutrition advice for 24 weeks. The primary endpoint was ospitalization due to stroke recurrence and new onset of coronary heart disease. We also evaluated blood pressure, serum lipid profile and hemoglobin A1c to compare the efficacy of the lifestyle modification intervention. Results: This trial was terminated earlier than expected because the prespecified early stopping rule for efficacy had been met. After 24 weeks intervention period, the intervention group showed a significant decrease in the clinic and home blood pressure and significant increase in the high density lipoprotein cholesterol (HDL-C) levels from the baseline to the 6-month assessment (clinic and home SBP, P <0.001; HDL-C, P =0.018), with significant differences between the randomized groups (clinic and home SBP, P <0.001; HDL-C, P =0.022). Median duration of follow-up was 2.9 years, 12 patients allocated the control group and 1 patient allocated the lifestyle intervention group had at least one major vascular event. A sequential plans analysis indicated that lifestyle intervention superior to control in interim analysis. Kaplan-Meier survival curves after log-rank test showed significant prognostic difference between randomized groups ( P =0.005). Conclusions: In conclusion, the results of this study indicate that lifestyle intervention is beneficial for preventing stroke recurrence and other vascular events.

scholarly journals Effect of Steamed Potato Bread Intake on Glucose, Lipids, and Urinary Na+ and K+: A Randomized Controlled Trial with Adolescents

2020 ◽  
Vol 17 (6) ◽  
pp. 2096
Author(s):  
Haiquan Xu ◽  
Yanzhi Guo ◽  
Shijun Lu ◽  
Yunqian Ma ◽  
Xiuli Wang ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Randomized Controlled Trial ◽  
Systolic Blood Pressure ◽  
Total Cholesterol ◽  
Controlled Trial ◽  
Intervention Group ◽  
High Density Lipoproteins ◽  
Control Group ◽  
Randomized Controlled ◽  
Potato Bread

Although potatoes are highly nutritious, many epidemiological studies have connected their consumption with abnormal lipids, diabetes, and hypertension. Steamed potato bread has recently become one of China’s staple foods. A randomized controlled trial was designed to evaluate the effect of steamed potato bread consumption on Chinese adolescents. Four classes from a high school were randomly selected and assigned to the intervention group (two classes) or control group (two classes). The steamed wheat bread (100% raw wheat flour) and potato bread (raw wheat flour to cooked potato flour ratio of 3:7) were provided to the control group and intervention group as staple food once a school day for 8 weeks, respectively. Compared with the control group, the intervention group had significant net changes in systolic blood pressure (4.6 mmHg, p = 0.010), insulin (−4.35 mIU/L, p < 0.001), total cholesterol (−0.13 mmol/L, p = 0.032), and high-density lipoproteins cholesterol (−0.07 mmol/L, p = 0.010). The urinary level of Na+/K+ did not differ between the groups. In conclusion, the intake of steamed potato bread for 8 weeks resulted in positive effects on the total cholesterol and insulin profiles but a negative effect on the systolic blood pressure and high-density lipoproteins cholesterol of adolescents.

scholarly journals Mobile Delivery of the Diabetes Prevention Program in People With Prediabetes: Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Tatiana Toro-Ramos ◽  
Andreas Michaelides ◽  
Maria Anton ◽  
Zulekha Karim ◽  
Leah Kang-Oh ◽  
...  
Keyword(s):  
Weight Loss ◽  
Randomized Controlled Trial ◽  
Prevention Program ◽  
Diabetes Prevention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Diabetes Prevention Program ◽  
Control Group ◽  
Significant Weight Loss ◽  
Randomized Controlled

BACKGROUND The Centers for Disease Control and Prevention (CDC) diabetes prevention program (DPP) has formed the foundation for Type 2 Diabetes Mellitus (T2DM) prevention efforts and lifestyle change modifications in multiple care settings. To our knowledge, no randomized controlled trial has verified the efficacy of a fully mobile version of CDC’s diabetes prevention program (DPP). OBJECTIVE This study aimed to investigate the long-term weight loss and glycemic efficacy of a mobile-delivered DPP compared with a control group receiving usual medical care. METHODS Adults with prediabetes (N=202) were recruited from a clinic and randomized to either a mobile-delivered, coach-guided DPP (Noom) or a control group that received regular medical care including a paper-based DPP curriculum and no formal intervention. The intervention group learned how to use the Noom program, how to interact with their coach, and the importance of maintaining motivation. They had access to an interactive coach-to-participant interface and group messaging, daily challenges for behavior change, DPP-based education articles, food logging, and automated feedback. Primary outcomes included changes in weight and hemoglobin A<sub>1c</sub> (HbA<sub>1c</sub>) levels at 6 and 12 months, respectively. Exploratory secondary outcomes included program engagement as a predictor of changes in weight and HbA<sub>1c</sub> levels. RESULTS A total of 202 participants were recruited and randomized into the intervention (n=101) or control group (n=99). In the intention-to-treat (ITT) analyses, changes in the participants’ weight and BMI were significantly different at 6 months between the intervention and control groups, but there was no difference in HbA<sub>1c</sub> levels (mean difference 0.004%, SE 0.05; <i>P</i>=.94). Weight and BMI were lower in the intervention group by −2.64 kg (SE 0.71; <i>P</i>&lt;.001) and −0.99 kg/m2 (SE 0.29; <i>P</i>=.001), respectively. These differences persisted at 12 months. However, in the analyses that did not involve ITT, program completers achieved a significant weight loss of 5.6% (SE 0.81; <i>P</i>&lt;.001) at 6 months, maintaining 4.7% (SE 0.88; <i>P</i>&lt;.001) of their weight loss at 12 months. The control group lost −0.15% at 6 months (SE 0.64; <i>P</i>=.85) and gained 0.33% (SE 0.70; <i>P</i>=.63) at 12 months. Those randomized to the intervention group who did not start the program had no meaningful weight or HbA<sub>1c</sub> level change, similar to the control group. At 1 year, the intervention group showed a 0.23% reduction in HbA<sub>1c</sub> levels; those who completed the intervention showed a 0.28% reduction. Those assigned to the control group had a 0.16% reduction in HbA<sub>1c</sub> levels. CONCLUSIONS This novel mobile-delivered DPP achieved significant weight loss reductions for up to 1 year compared with usual care. This type of intervention reduces the risk of overt diabetes without the added barriers of in-person interventions. CLINICALTRIAL ClinicalTrials.gov NCT03865342; https://clinicaltrials.gov/ct2/show/NCT03865342

scholarly journals Push Notifications From a Mobile App to Improve the Body Composition of Overweight or Obese Women: Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Alberto Hernández-Reyes ◽  
Fernando Cámara-Martos ◽  
Guillermo Molina Recio ◽  
Rafael Molina-Luque ◽  
Manuel Romero-Saldaña ◽  
...  
Keyword(s):  
Physical Activity ◽  
Clinical Trial ◽  
Weight Loss ◽  
Body Composition ◽  
Controlled Trial ◽  
Intervention Group ◽  
The Body ◽  
Control Group ◽  
Obese Women ◽  
Randomized Controlled

BACKGROUND Technology—in particular, access to the Internet from a mobile device—has forever changed the way we relate to others and how we behave in our daily life settings. In recent years, studies have been carried out to analyze the effectiveness of different actions via mobile phone in the field of health: telephone calls, short message service (SMS), telemedicine, and, more recently, the use of push notifications. We have continued to explore ways to increase user interaction with mobile apps, one of the pending subjects in the area of mHealth. By analyzing the data produced by subjects during a clinical trial, we were able to extract behavior patterns and, according to them, design effective protocols in weight loss programs. OBJECTIVE A clinical trial was proposed to (1) evaluate the efficacy of push notifications in an intervention aimed at improving the body composition of adult women who are overweight or obese, through a dietary procedure, and (2) analyze the evolution of body composition based on push notifications and prescribed physical activity (PA). METHODS A two-arm randomized controlled trial was carried out. A sample size of 117 adult obese women attended a face-to-face, 30-minute consultation once a week for 6 months. All patients were supplied with an app designed for this study and a pedometer. The control group did not have access to functionalities related to the self-monitoring of weight at home, gamification, or prescription of PA. The intervention group members were assigned objectives to achieve a degree of compliance with diet and PA through exclusive access to specific functionalities of the app and push notifications. The same diet was prescribed for all patients. Three possible PA scenarios were studied for both the control and intervention groups: light physical activity (LPA), moderate physical activity (MPA), and intense physical activity (IPA). For the analysis of three or more means, the analysis of variance (ANOVA) of repeated means was performed to evaluate the effects of the intervention at baseline and at 3 and 6 months. RESULTS Receiving notifications during the intervention increased body fat loss (mean -12.9% [SD 6.7] in the intervention group vs mean -7.0% [SD 5.7] in the control group; <i>P</i>&lt;.001) and helped to maintain muscle mass (mean -0.8% [SD 4.5] in the intervention group vs mean -3.2% [SD 2.8] in the control group; <i>P</i>&lt;.018). These variations between groups led to a nonsignificant difference in weight loss (mean -7.9 kg [SD 3.9] in the intervention group vs mean -7.1 kg [SD 3.4] in the control group; <i>P</i>&gt;.05). CONCLUSIONS Push notifications have proven effective in the proposed weight loss program, leading women who received them to achieve greater loss of fat mass and a maintenance or increase of muscle mass, specifically among those who followed a program of IPA. Future interventions should include a longer evaluation period; the impact of different message contents, as well as message delivery times and frequency, should also be researched. CLINICALTRIAL ClinicalTrials.gov NCT03911583; https://www.clinicaltrials.gov/ct2/show/NCT03911583

scholarly journals Weight Loss After Stroke Through an Intensive Lifestyle Intervention (Group Lifestyle Balance-Cerebrovascular Accident): Protocol for a Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Simon Driver ◽  
Chad Swank ◽  
Katherine Froehlich-Grobe ◽  
Evan McShan ◽  
Stephanie Calhoun ◽  
...  
Keyword(s):  
Weight Loss ◽  
Randomized Controlled Trial ◽  
Weight Gain ◽  
Emotional Disorders ◽  
Cerebrovascular Accident ◽  
Recurrent Stroke ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled

BACKGROUND Weight gain can be a consequence of stroke, or cerebrovascular accident (CVA), because of impaired mobility, behavioral and emotional disorders, and sensory losses. Weight gain increases the patient’s risk of recurrent stroke and chronic diseases, such as diabetes, metabolic syndrome, and pulmonary and heart disease. Approaches to weight loss in this population are lacking, although necessary because of the unique physiological and cognitive needs of persons after a stroke. Evidence shows that intensive behavioral therapy interventions that address both physical activity and diet offer the greatest potential for weight loss. The Group Lifestyle Balance (GLB) intervention is a 12-month, evidence-based weight loss program that has been used extensively with the general population; this program was modified to meet the needs of people who have had a stroke (GLB-CVA). OBJECTIVE This randomized controlled trial (RCT) aims to examine the efficacy of the GLB-CVA on weight and secondary outcomes, compared with that of a waitlist control group. METHODS This RCT will enroll and randomize 64 patients over an 18-month period. RESULTS Currently, 51 people are waitlisted, with 23 out of 51 screened and 16 out of 23 eligible. CONCLUSIONS It is anticipated that the findings from this RCT will contribute to the evidence base regarding weight loss strategies for people living with stroke. CLINICALTRIAL ClinicalTrials.gov NCT03873467; https://clinicaltrials.gov/ct2/show/NCT03873467. INTERNATIONAL REGISTERED REPORT PRR1-10.2196/14338

scholarly journals A Smartphone App to Restore Optimal Weight (SPAROW) in Women With Recent Gestational Diabetes Mellitus: Randomized Controlled Trial

10.2196/22147 ◽  
2021 ◽  
Vol 9 (3) ◽  
pp. e22147
Author(s):  
Karen Lim ◽  
Shiao-Yng Chan ◽  
Su Lin Lim ◽  
Bee Choo Tai ◽  
Cammy Tsai ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Weight Loss ◽  
Controlled Trial ◽  
Intervention Group ◽  
Caloric Intake ◽  
First Trimester ◽  
Control Group ◽  
Optimal Weight ◽  
Randomized Controlled

Background Women with a history of gestational diabetes mellitus (GDM) are at an increased risk of developing type 2 diabetes mellitus (T2DM). Lifestyle interventions aimed at postpartum weight loss to reduce T2DM risk have been reported, but poor compliance remains a barrier. Smartphone-based interventions may improve compliance, but data on its use in women with recent GDM are limited. Objective This trial aimed to investigate the efficacy of a smartphone app in restoring optimal weight following delivery in women with GDM, in the setting of a population with high rates of GDM and type 2 diabetes. Methods In this unblinded randomized controlled trial, 200 women with GDM were randomized to receive the intervention or standard care following delivery. The intervention enabled logging of weight, meals, and activity, with web-based interaction with a team comprising dieticians, a physiotherapist, and an occupational therapist. The primary outcome was an achievement of optimal weight (defined as the restoration of first trimester weight if first trimester BMI≤23 kg/m2 or weight loss of at least 5% from first trimester weight if first trimester BMI>23 kg/m2) at 4 months post partum. Secondary outcome measures included absolute weight loss, serum metabolic markers, self-reported nutritional intake, health education, and quality of life via questionnaires and user engagement in the intervention group. Results In total, 40% (38/96) of women in the intervention group achieved optimal weight at 4 months post delivery compared with 32% (28/93) in the control group (P=.27). Compared with the control group, women in the intervention group reported significantly reduced caloric intake at 4 months after delivery (P<.001) and higher health-directed behavior scores (P=.045). The intervention group also reported increased emotional distress scores (P=.01). At 4 months, participant engagement with the intervention was maintained at 60.8% (SD 33.9%). Conclusions Although a statistically significant increase in women achieving healthy weight was not observed, this app remains promising, as women in the intervention group reported improved health behaviors and lower caloric intake. Importantly, the high retention rates suggest that a larger study with a longer follow-up period might confirm the effectiveness of this app for weight management. Trial Registration ClinicalTrials.gov NCT03324737; https://clinicaltrials.gov/ct2/show/NCT03324737 International Registered Report Identifier (IRRID) RR2-10.1186/s12889-019-7691-3

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