Psychological Outcomes and Predictors of Weight Loss in Adolescents With Severe Obesity Following a Reversible Endoscopic Bariatric Procedure

Introduction: Adolescent and children obesity is a growing concern worldwide. Bariatric surgery is used as an effective treatment for adolescents with obesity and provides physical and mental health benefits. Application of alternative, minimally invasive, safe, and reversible endoscopic procedures, such as the Duodenojejunal bypass liner (DJBL), has been recently suggested as an effective treatment for adolescents with obesity. We explored specific psychological outcomes of adolescents with obesity during a year of follow-up after undergoing a reversible endoscopic bariatric procedure, and a year after removal. We were also interested in identifying psychological factors that could predict successful weight loss after the procedure.Methods: Nineteen adolescent with severe obesity undergoing DJBL procedure were psychologically assessed in an open-label, prospective clinical trial (NTC0218393), at the implantation of device and at the removal of device after 12 months. Control group of 26 adolescents with severe obesity were recruited from the same outpatient clinic undergoing only conservative treatment. In addition, adolescents from the intervention group were followed for 12 months after the removal of the device. The Youth Self Report (YSR) was used to assess adolescents' emotional and behavioural problems; The Multidimensional Body-Self Relations Questionnaire (MBSRQ) to assess body image and The Eating Disorder Examination Questionnaire (EDE-Q) to assess attitudes and behaviours related to eating disorder.Results: Significant improvements in somatic complain (F = 12.478, p = 0.001), emotional and behavioural problems (F = 7.169, p = 0.011) and food restraining (F = 9.605, p = 0.004) were found in the intervention group at device removal compared to the control group. Moreover, at the time of device removal compared to baseline, improvements in several psychological outcomes were found (F = 32.178 p = 0.000 for emotional and behavioural problems). Adolescents also became more satisfied with their appearance (F = 6.789, p = 0.019). Majority of observed changes remained stable at the next follow up a year after the device removal. Significant predictors of successful weight loss at device removal were fewer overeating episodes (B = 0.147, p = 0.022) and lower body satisfaction (B = 0.932, p = 0.013).Discussion: Following a reversible bariatric procedure, improvements of psychological (emotional and behavioural) factors were found in adolescents with severe obesity. Psychological predictors of successful weight loss were identified, showing the greatest importance of eating behaviour and body satisfaction in successful weight loss.

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Randomized Trial for Weight Loss Using a Digital Therapeutic Application

Journal of Diabetes Science and Technology ◽

10.1177/19322968211000815 ◽

2021 ◽

pp. 193229682110008

Author(s):

Tryggvi Thorgeirsson ◽

Johanna E. Torfadottir ◽

Erlendur Egilsson ◽

Saemundur Oddsson ◽

Thrudur Gunnarsdottir ◽

...

Keyword(s):

Weight Loss ◽

Mobile Application ◽

Intervention Group ◽

Lifestyle Change ◽

Noncommunicable Diseases ◽

Control Group ◽

Intention To Treat ◽

Protocol Group ◽

Lifestyle Program ◽

Program Intervention

Background: Smartphones present a near-ubiquitous channel through which structured lifestyle change can reduce risk or progression of the most common noncommunicable diseases. We explored whether a digital structured lifestyle program enhances weight loss. Methods: We randomized overweight and obese participants attending a four-month lifestyle change program to either standard weekly coaching sessions (controls), or standard treatment supplemented with a digital therapeutic mobile application (intervention). Changes in body mass index after four months were the main outcome measure. Odds ratios of achieving 5% weight loss were estimated with unconditional logistic regression. Results: Of 234 eligible persons, 146 (62%) agreed to participate, were block-randomized, showed up for the baseline measures, and constituted the intention-to-treat (ITT) sample ( n = 95 intervention group, n = 51 control group). In the intervention group, 70 (74%) downloaded the mobile application and completed the program (intervention per-protocol). Significant weight loss and BMI reduction were observed for both the intention-to-treat intervention group ( P < 0.05, P = 0.01) and the per-protocol intervention group ( P < 0.0001, P < 0.0001). For the intervention per-protocol group, the odds ratio of achieving 5% weight loss, compared to not treated per-protocol, was 3.3 (95% CI 1.3-8.2), adjusting for age and weight at baseline.Attendance to weekly coaching sessions decreased by 18% during the program in the control group while it increased by 3% amongst the per-protocol group ( P = 0.004). Conclusions: These preliminary findings support the benefit of a digital therapeutic to enhance weight reduction and attendance in a structured lifestyle change program. Larger trials of longer duration are needed to confirm these findings.

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Successful weight loss reduces endothelial activation in individuals with severe obesity participating in a multimodal weight loss program

Obesity Research & Clinical Practice ◽

10.1016/j.orcp.2021.03.013 ◽

2021 ◽

Author(s):

Sabine J.M. Sag ◽

Christina Strack ◽

Judith Zeller ◽

Margareta Mohr ◽

Thomas Loew ◽

...

Keyword(s):

Weight Loss ◽

Severe Obesity ◽

Endothelial Activation ◽

Weight Loss Program ◽

Successful Weight Loss

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The Effectiveness of a Healthcare Application and Human Coaching Program in Primary Care Clinics: A Non-randomized Controlled Trial (Preprint)

10.2196/preprints.34531 ◽

2021 ◽

Author(s):

HyoRim Ju ◽

EunKyo Kang ◽

YoungIn Kim ◽

HyunYoung Ko ◽

Belong Cho

Keyword(s):

Primary Care ◽

Weight Loss ◽

Sleep Quality ◽

Chronic Conditions ◽

Chronic Condition ◽

Intervention Group ◽

Self Management ◽

Control Group ◽

Primary Care Clinics ◽

Healthcare Application

BACKGROUND As the global burden of chronic conditions increases, effective management for these are a concern. There is an increasing need for chronic condition management using mobile self-management healthcare applications. OBJECTIVE This study evaluated the effectiveness of a mobile self-management healthcare application combined with human coaching for primary care services in patients with chronic conditions. METHODS A total of 110 patients with hypertension, diabetes, dyslipidemia, and/or metabolic syndrome who visited one of 17 participating primary care clinics from September 2020 to November 2020 were included in this study. Data regarding changes in body weight, sleep conditions, quality of life, depression, anxiety, stress, body mass index, waist circumference, blood sugar levels, blood pressure, and blood lipids levels were recorded. The intervention group (N=65) used a mobile self-management healthcare application with human coaching for 12 weeks, and the control group (N=45) underwent conventional, self-managed health care. RESULTS Patients in the intervention group reported significantly more weight loss than those in the control group (P=.002). The weight loss was markedly greater after using application for nine weeks than using it for four weeks or five to eight weeks (P=.002). Patients in the intervention group reported better sleep quality (P=.04) and duration (P=.004) than those in the control group. CONCLUSIONS The combination of a mobile self-management healthcare application and human coaching in primary care clinics results in better management of chronic conditions. The observed weight loss was greater and sleep quality improved than conventional primary care for patients with at least one chronic condition.

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Results of the Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) Trial: A Behavioral Weight Loss Intervention in Overweight or Obese Breast Cancer Survivors

Journal of Clinical Oncology ◽

10.1200/jco.2015.61.1095 ◽

2015 ◽

Vol 33 (28) ◽

pp. 3169-3176 ◽

Cited By ~ 98

Author(s):

Cheryl L. Rock ◽

Shirley W. Flatt ◽

Tim E. Byers ◽

Graham A. Colditz ◽

Wendy Demark-Wahnefried ◽

...

Keyword(s):

Breast Cancer ◽

Blood Pressure ◽

Weight Loss ◽

Breast Cancer Mortality ◽

Intervention Group ◽

Good Health ◽

Control Group ◽

Weight Loss Intervention ◽

Behavioral Weight Loss ◽

Behavioral Weight Loss Intervention

Purpose Obesity increases risk for all-cause and breast cancer mortality and comorbidities in women who have been diagnosed and treated for breast cancer. The Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) study is the largest weight loss intervention trial among survivors of breast cancer to date. Methods In this multicenter trial, 692 overweight/obese women who were, on average, 2 years since primary treatment for early-stage breast cancer were randomly assigned to either a group-based behavioral intervention, supplemented with telephone counseling and tailored newsletters, to support weight loss or a less intensive control intervention and observed for 2 years. Weight and blood pressure were measured at 6, 12, 18, and 24 months. Longitudinal mixed models were used to analyze change over time. Results At 12 months, mean weight loss was 6.0% of initial weight in the intervention group and 1.5% in the control group (P < .001). At 24 months, mean weight loss in the intervention and control groups was 3.7% and 1.3%, respectively (P < .001). Favorable effects of the intervention on physical activity and blood pressure were observed. The weight loss intervention was more effective among women older than 55 years than among younger women. Conclusion A behavioral weight loss intervention can lead to clinically meaningful weight loss in overweight/obese survivors of breast cancer. These findings support the need to conduct additional studies to test methods that support sustained weight loss and to examine the potential benefit of intentional weight loss on breast cancer recurrence and survival.

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Effects of a Modified Mindfulness-Based Cognitive Therapy for Family Caregivers of People With Dementia: A Randomized Clinical Trial

The Gerontologist ◽

10.1093/geront/gnaa125 ◽

2020 ◽

Cited By ~ 1

Author(s):

Patrick Pui Kin Kor ◽

Justina Y W Liu ◽

Wai Tong Chien

Keyword(s):

Cognitive Therapy ◽

Family Caregivers ◽

Intervention Group ◽

Psychological Outcomes ◽

Control Group ◽

Dementia Caregiving ◽

Care Recipients ◽

People With Dementia ◽

T1 And T2

Abstract Background and Objectives Family caregivers of people with dementia (PWD) experience high levels of stress resulting from caregiving. This study aimed to investigate the effects of a modified of Mindfulness-Based Cognitive Therapy (MBCT) for dementia caregiving. Research Design and Methods 113 family caregivers of PWD were randomized to either the intervention group, receiving the 7-session modified MBCT for a period of 10 weeks with telephone follow-up or the control group, receiving the brief education on dementia care and usual care. The caregiving stress (primary outcome) and various psychological outcomes of caregivers and the behavioral and psychological symptoms of dementia (BPSD) in the care recipients were assessed and compared at baseline (T0), postintervention (T1), and at the 6-month follow-up (T2). Results At both T1 and T2, the intervention group had a statistically greater improvement in stress (p = .02 and .03), depression (p = .001 and .04), anxiety (p = .007 and .03), and BPSD-related caregivers’ distress (p = .003 and p = .04). A significant greater improvement was also demonstrated in mental health-related quality of life at T2 (p = .001) and BPSD of the care recipients at T1 (p = .04). The increased caregivers’ level of mindfulness was significantly correlated with the improvement of various psychological outcomes at T1 and T2 with a correlation coefficient −0.64 to 0.43. Discussion and Implications The modified MBCT enhanced the level of mindfulness in the caregivers and was effective to reduce the caregivers’ stress and promote their psychological well-being during a 6-month follow-up. Future research is recommended to further examine its effects on the varieties of psychological and behavioral outcomes of both caregivers and care recipients and their dyadic relationships, as well as explore its mechanism of action in facilitating dementia caregiving. Clinical Trials Registration Number NCT03354819

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Worksite weight management program

Nutrition & Food Science ◽

10.1108/nfs-08-2016-0132 ◽

2017 ◽

Vol 47 (4) ◽

pp. 490-510 ◽

Cited By ~ 1

Author(s):

Jian Pei Kong ◽

Linda Jok ◽

Azlee Bin Ayub ◽

Rawa Ak Bau

Keyword(s):

Weight Loss ◽

Body Weight ◽

Primary Healthcare ◽

Fasting Blood Glucose ◽

Intervention Group ◽

Healthcare Setting ◽

Control Group ◽

Short Term ◽

Content Type ◽

Worksite Intervention

Purpose This study aims to pilot test a new multi-component worksite intervention for weight loss in a primary healthcare setting. Design/methodology/approach This randomized trial involved 88 participants (43, 45; intervention, control group). The intervention group enrolled in a 12-week lifestyle program that involved modification of dietary intake by community Registered Dietitian (RDs) and increasing high-intensity interval training (HITT) with motivational interviewing (MI) to support changes. The control group received traditional counselling and weekly aerobic exercise from Medical Officer and physiotherapist. The primary outcome measure was the changes in body weight. Secondary measures were changes in blood pressure, fasting blood glucose, fasting blood lipid and dietary changes. Assessments were repeated at a three-month interval. Findings There was a significant reduction in body weight and waist circumference within groups. Intervention group demonstrated a significant improvement in all cardiometabolic risk factors. This study showed that primary healthcare setting can be successful locations in promoting short-term health benefits. RDs were more successful and HITT appeared to be a favorable workout with MI in achieving drastic weight loss. Research limitations/implications The short-term worksite intervention and not recording of body composition were the major drawbacks in this study. Originality/value The efficacy of multi-component worksite intervention (Diet–HITT–MI) in primary healthcare setting has not been clearly defined.

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Effect of a combined diet plus exercise intervention on weight loss, physical fitness, and cancer-related fatigue among Japanese women with breast cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.e21658 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. e21658-e21658 ◽

Cited By ~ 1

Author(s):

Koki Okumatsu ◽

Takehiko Tsujimoto ◽

Akina Seki ◽

Teruo Yamauchi ◽

Hideko Yamauchi ◽

...

Keyword(s):

Breast Cancer ◽

Weight Loss ◽

Physical Fitness ◽

Cancer Patients ◽

Endocrine Therapy ◽

Intervention Group ◽

Exercise Program ◽

Control Group ◽

Breast Cancer Patients ◽

Cancer Related Fatigue

e21658 Background: Weight gain, deterioration of physical fitness, and cancer-related fatigue often occur in the breast cancer patients mainly due to endocrine therapy. A number of previous studies have reported that obesity increases the risk of breast cancer recurrence and death, while exercise habituation improves physical fitness and fatigue among breast cancer patients. However, almost all studies have been conducted in the Western community and there are few studies focused on Asian women who may have lower BMI compared with the Western ones. Therefore, we investigated whether a combined diet plus exercise program affects weight loss, physical fitness and fatigue indices among Japanese breast cancer patients undergoing endocrine therapies. Methods: Thirty-two Japanese women with breast cancer undergoing endocrine therapy (age; 50±6 years, body weight; 57±10 kg) were voluntarily assigned to either intervention group (n = 21) or control group (n = 11). The intervention group completed a 12-week combined diet plus exercise program, consisting of weekly diet instruction classes aimed at maintaining a nutritionally well-balanced 1,200 kcal/d diet and a weekly 90-min exercise session. Anthropometric indices, physical fitness, blood sample and cancer-related fatigue were measured at baseline and after the 12-week program. Results: All of the 21 women completed the 12-week program. Mean weight loss was 8.7% of the initial weight in the intervention group and 0.1% in the control group ( P < . 001). Significant improvements were observed in cardiorespiratory fitness ( P < .01), flexibility ( P < .01) and agility ( P < .01) in the intervention group. Cancer related-fatigue scores decreased by 7.9 points (39%) among the intervention group ( P < .001), while it remained essentially unchanged among the control group. No adverse events were reported in the intervention group. Conclusions: A combined diet plus exercise program may contribute to a decrease in body weight and improvement in physical fitness and cancer-related fatigue. Further study is needed to help reduce side effects due to endocrine therapy and enhance quality of life among Asian breast cancer patients. Clinical trial information: UMIN000025890.

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

10.2196/preprints.17842 ◽

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 A1c (HbA1c) levels at 6 and 12 months, respectively. Exploratory secondary outcomes included program engagement as a predictor of changes in weight and HbA1c 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 HbA1c levels (mean difference 0.004%, SE 0.05; P=.94). Weight and BMI were lower in the intervention group by −2.64 kg (SE 0.71; P<.001) and −0.99 kg/m2 (SE 0.29; P=.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; P<.001) at 6 months, maintaining 4.7% (SE 0.88; P<.001) of their weight loss at 12 months. The control group lost −0.15% at 6 months (SE 0.64; P=.85) and gained 0.33% (SE 0.70; P=.63) at 12 months. Those randomized to the intervention group who did not start the program had no meaningful weight or HbA1c level change, similar to the control group. At 1 year, the intervention group showed a 0.23% reduction in HbA1c levels; those who completed the intervention showed a 0.28% reduction. Those assigned to the control group had a 0.16% reduction in HbA1c 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

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SUN-LB115 Is the Stepping-Down Approach a Better Option Than Multiple Daily Injections in Patients With Chronic Poorly-Controlled Diabetes on Advanced Insulin Therapy?

Journal of the Endocrine Society ◽

10.1210/jendso/bvaa046.2247 ◽

2020 ◽

Vol 4 (Supplement_1) ◽

Author(s):

Soe Naing ◽

Geeta Ramesh ◽

Jasmine Garcha ◽

Anupama Poliyedath ◽

Stutee Khandelwal ◽

...

Keyword(s):

Weight Loss ◽

Patient Satisfaction ◽

Insulin Therapy ◽

Basal Insulin ◽

Intervention Group ◽

Secondary Outcome ◽

Control Group ◽

Obese Patients ◽

Daily Insulin ◽

Combined Use

Abstract In the traditional step-up approach, patients with poorly-controlled T2DM are eventually advanced to multiple daily insulin injections (MDI). However, some on advanced insulin therapy (AIT) continue to have poor control due to poor compliance with MDI and fear of insulin-induced weight gain. The recent guidelines recommend the use of anti-hyperglycemic agents with weight loss benefits, such as SGLT2i or GLP1 RA, with basal insulin before the patients are advanced to MDI. Objective: To determine if de-escalating from AIT to the combined use of metformin, SGLT2i, GLP1 RA and basal insulin by using the stepping-down approach is a better option than MDI in obese patients with poorly- controlled T2DM on AIT. Research Design: This pilot, prospective, randomized, open-label, controlled, parallel-group trial enrolled 22 obese patients with T2DM on AIT, who had BMI ≥30 kg/m2, A1c >8% and eGFR >45. Patients were randomized to either intervention (Step-Down) or control (MDI) group. In the control group, the patient was advised to remain on MDI. In the intervention group, all prandial insulin injections were discontinued; but the patient remained on the basal insulin and metformin to which SGLT2i, Empagliflozin, and GLP1 RA, Dulaglutide, were added. They were followed up for 16 weeks. The primary outcome was A1c change and secondary outcomes were the change in fasting BG, weight, BP, HR, fasting lipids, serum Na and K, serum Cr, liver enzymes, CBC and Diabetes Medications Satisfaction (DM-SAT) scores at 16 weeks. Results: There was no difference in A1c between 2 groups (10.36% vs 9.69%;p=0.171) at baseline. However, A1c was significantly lower at 4 weeks (9.54% vs 7.31%; p=0.0088) and 16 weeks (9.7% vs 8.25%; p<0.001) in intervention group (n=10). Compared to baseline, in the control group (n=8), there was no significant change at secondary outcome variables except slightly higher SBP at 16 weeks. In intervention group, compared to baseline, there was a significant decrease in weight (-16.38 Lbs; p=0.003), BMI (-3.06; p<0.001), LDL cholesterol (-15.7 mg/d; p=0.0378), total cholesterol (-18.5 mg/dL; p=0.0386), total daily insulin dose (-57.3 units; p<0.001) and a significant improvement in DM-SAT patient satisfaction 0-100 scores - total score (+45.3; p <0.001) and subscale scores (Convenience +35.28, p =0.019; Lifestyle +35.8, p=0.0052; Medical control +51.3, p<0.001; Wellbeing +47.2,p=0.0091) at 16 weeks. Conclusions: De-escalating from AIT to the combined use of metformin, SGLT2i, GLP1 RA and basal insulin in obese patients with poorly-controlled T2DM by using the stepping-down approach results in the significant improvement in glycemic control, weight loss, and significantly higher patient satisfaction. This noble stepping-down approach may be a better option than continuing MDI in such patients. This pilot study result needs to be confirmed with a larger trial. ClinicalTrials ID: NCT02846233

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‘You are Okay’: Effects of a support and educational program for children with mild intellectual disability and their parents with mental health concerns

Journal of Intellectual Disabilities ◽

10.1177/1744629520953765 ◽

2020 ◽

pp. 174462952095376

Author(s):

Ivon Riemersma ◽

F Van Santvoort ◽

KTM Van Doesum ◽

CMH Hosman ◽

JMAM Janssens ◽

...

Keyword(s):

Mental Health ◽

Group Care ◽

Behavioural Problems ◽

Control Group ◽

Emotional And Behavioural Problems ◽

Health Concerns ◽

Increased Risk ◽

Intermediate Outcomes ◽

Mental Health Concerns ◽

Experimental Group

Background: Children with mild intellectual disabilities and emotional and behavioural problems whose parents have mental health concerns are at an increased risk of developing problems themselves. This study analysed the effectiveness of the ‘You are Okay’-program aimed to support these children and parents and to reduce the risk of problem development in children. Method: A quasi-experimental design was used to compare the experimental group (‘care as usual’ and ‘You are Okay’) with the control group (‘care as usual’) on the main outcome of emotional and behavioural problems and proposed intermediate outcomes. Results: Children in the experimental group reported a significant medium to large decrease in emotional and behavioural problems compared to the control group. The effects on the intermediate outcomes were non-significant. Conclusions: This specific study population comprising a vulnerable group of children seems to benefit from this specially adapted ‘You are Okay’-program. More research is necessary to draw further conclusions.

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