scholarly journals Community-based weight loss programme targeting overweight Chinese adults with pre-diabetes: study protocol of a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (4) ◽  
pp. e035196
Author(s):  
Mandy Ho ◽  
Pui Hing Chau ◽  
Esther Yee Tak Yu ◽  
Michael Tin-cheung Ying ◽  
Cindy Lo Kuen Lam

IntroductionType 2 diabetes mellitus (T2DM) is one of the world’s fastest growing health problems. Asians have a strong ethnic predisposition for T2DM, developing T2DM at a lower degree of obesity and at younger ages than other ethnic groups. T2DM has a gradual onset, with most individuals progressing through a pre-diabetic state, providing an opportunity to prevent T2DM and its complications. This study aims to evaluate the effectiveness of a community-based lifestyle intervention programme on weight loss and improvements in insulin sensitivity and cardiometabolic profiles in Chinese adults with pre-diabetes.Methods and analysisThis study is a 12-month, assessor-blinded randomised controlled trial. Adults with pre-diabetes (aged 40–64 years, n=180) with pre-diabetes are randomised into either an intervention group (receiving group-based lifestyle interventions) or a control group (receiving text messages containing health information). The intervention programme targets a weight loss of 5% during the first 6 months by restricting caloric intake and increasing physical activity. Participants in the intervention group will attend six group sessions and two individual face-to-face diet counselling sessions during the first 6 months, followed by monthly telephone support during the 6-month maintenance phase. Participants in the control group will receive monthly text messages containing general health information only. The primary outcome is weight loss (%). Secondary outcomes include insulin sensitivity (assessed using fasting insulin level and homeostatic model assessment of insulin resistance), glycaemic control (assessed using glycated haemoglobin level), lipid profile, blood pressure, carotid artery thickness, dietary intake and level of physical activity. Intention-to-treat analysis will be conducted using a generalised linear mixed effects model with a logit link and linear mixed models.Ethics and disseminationThis study has been approved by the relevant research ethics committee. The results will be disseminated through peer-reviewed journals and scientific presentations.Trial registration numberNCT03609697.

Author(s):  
Mitch Duncan ◽  
Sasha Fenton ◽  
Wendy Brown ◽  
Clare Collins ◽  
Nicholas Glozier ◽  
...  

Background: This study compared the efficacy of two multi-component m-health interventions with a wait-list control group on body weight (primary outcome), and secondary outcomes of cardiovascular risk factors, lifestyle behaviours, and mental health. Methods: Three-arm randomised controlled trial (Enhanced: physical activity, diet, sleep, Traditional: physical activity, diet, Control) with assessments conducted at baseline, 6 and 12 months. Participants (n = 116) were overweight or obese adults aged 19–65 (M = 44.5 [SD = 10.5]). The 6-month intervention was delivered via a smartphone app providing educational materials, goal-setting, self-monitoring and feedback, and also included one face-to-face dietary consultation, a Fitbit and scales. The trial was prospectively registered and conducted between May 2017 and September 2018. Group differences on primary and secondary outcomes were examined between the Pooled Intervention groups (Pooled Intervention = Enhanced and Traditional) and Control groups, and then between Enhanced and Traditional groups. Results: Nineteen participants (16.4%) formally withdrew from the trial. Compared with the Control group, average body weight of the Pooled Intervention group did not differ at 6 (between-group difference = −0.92, (95% CI −3.33, 1.48)) or 12 months (0.00, (95% CI −2.62, 2.62)). Compared with the Control group, the Pooled Intervention group significantly increased resistance training (OR = 7.83, (95% CI 1.08, 56.63)) and reduced energy intake at 6 months (−1037.03, (−2028.84, −45.22)), and improved insomnia symptoms at 12 months (−2.59, (−4.79, −0.39)). Compared with the Traditional group, the Enhanced group had increased waist circumferences (2.69, (0.20, 5.18)) and sedentary time at 6 months (105.66, (30.83, 180.48)), and improved bed time variability at 12 months (−1.08, (−1.86, −0.29)). No other significant differences were observed between groups. Conclusions: Relative to Controls, the Pooled Intervention groups did not differ on body weight but improved resistance training, and reduced energy intake and insomnia symptom severity. No additional weight loss was apparent when targeting improvements in physical activity, diet and sleep in combination compared with physical activity and diet.


Nutrients ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 2468
Author(s):  
Sasha Fenton ◽  
Tracy L. Burrows ◽  
Clare E. Collins ◽  
Anna T. Rayward ◽  
Beatrice Murawski ◽  
...  

This three-arm randomised controlled trial evaluated whether (1) a multi-component weight loss intervention targeting diet, physical activity (PA), and sleep was effective at improving dietary intake over six months and 12 months, compared with a control, and (2) the enhanced diet, PA, and sleep intervention was more effective at improving dietary intake than the traditional diet and PA intervention. A total of 116 adults (70% female, 44.5 years, BMI 31.7 kg/m2) were randomised to either traditional diet and PA intervention; enhanced diet, PA, and sleep intervention; or wait-list control. To examine between-group differences, intervention groups were pooled and compared with the control. Then, the two intervention groups were compared. At six months, the pooled intervention group consumed 1011 fewer kilojoules/day (95% CI −1922, −101), less sodium (−313.2 mg/day; 95% CI −591.3, −35.0), and higher %EI from fruit (+2.1%EI; 95% CI 0.1, 4.1) than the controls. There were no differences in intake between the enhanced and traditional groups at six months. At 12 months, the pooled intervention and control groups reported no significant differences. However, compared to the traditional group, the enhanced reported higher %EI from nutrient-dense foods (+7.4%EI; 95% CI 1.3, 13.5) and protein (+2.4%EI; 95% CI 0.1, 4.6), and reduced %EI from fried/takeaway foods (−3.6%EI; 95% CI −6.5, −0.7), baked sweet products (−2.0%EI; 95% CI −3.6, −0.4), and packaged snacks (−1.1%EI; 95% CI −2.2, −0.3). This weight loss intervention reduced total energy and sodium intakes as well as increased fruit intake in adults at six months. The enhanced intervention group reported improved dietary intake relative to the traditional group at 12 months.


BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e022637 ◽  
Author(s):  
Sheikh Mohammed Shariful Islam ◽  
Clara K Chow ◽  
Julie Redfern ◽  
Cindy Kok ◽  
Karin Rådholm ◽  
...  

ObjectiveWe aimed to evaluate the effects on depression scores of a lifestyle-focused cardiac support programme delivered via mobile phone text messaging among patients with coronary heart disease (CHD).DesignSubstudy and secondary analysis of a parallel-group, single-blind randomised controlled trial of patients with CHD.SettingA tertiary hospital in Sydney, Australia.InterventionThe Tobacco, Exercise and dieT MEssages programme comprised four text messages per week for 6 months that provided education, motivation and support on diet, physical activity, general cardiac education and smoking, if relevant. The programme did not have any specific mental health component.OutcomesDepression scores at 6 months measured using the Patient Health Questionnaire-9 (PHQ-9). Treatment effect across subgroups was measured using log-binomial regression model for the binary outcome (depressed/not depressed, where depressed is any score of PHQ-9 ≥5) with treatment, subgroup and treatment by subgroup interaction as fixed effects.ResultsDepression scores at 6 months were lower in the intervention group compared with the control group, mean difference 1.9 (95% CI 1.5 to 2.4, p<0.0001). The frequency of mild or greater depressive symptoms (PHQ-9 scores≥5) at 6 months was 21/333 (6.3%) in the intervention group and 86/350 (24.6%) in the control group (relative risk (RR) 0.26, 95% CI 0.16 to 0.40, p<0.001). This proportional reduction in depressive symptoms was similar across groups defined by age, sex, education, body mass index, physical activity, current smoking, current drinking and history of depression, diabetes and hypertension. In particular, the rates of PHQ-9 ≥5 among people with a history of depression were 4/44 (9.1%) vs 29/62 (46.8%) in intervention vs control (RR 0.19, 95% CI 0.07 to 0.51, p<0.001), and were 17/289 (5.9%) vs 57/288 (19.8%) among others (RR 0.30, 95% CI 0.18 to 0.50, p<0.001).ConclusionsAmong people with CHD, a cardiac support programme delivered via mobile phone text messaging was associated with fewer symptoms of mild-to-moderate depression at 6 months in the treatment group compared with controls.Trial registration numberACTRN12611000161921.


BMJ Open ◽  
2017 ◽  
Vol 7 (10) ◽  
pp. e017159 ◽  
Author(s):  
Lynsay Matthews ◽  
Juliana Pugmire ◽  
Laurence Moore ◽  
Mark Kelson ◽  
Alex McConnachie ◽  
...  

IntroductionHelpMeDoIt! will test the feasibility of an innovative weight loss intervention using a smartphone app and website. Goal setting, self-monitoring and social support are three key facilitators of behaviour change. HelpMeDoIt! incorporates these features and encourages participants to invite ‘helpers’ from their social circle to help them achieve their goal(s).AimTo test the feasibility of the intervention in supporting adults with obesity to achieve weight loss goals.Methods and analysis12-month feasibility randomised controlled trial and accompanying process evaluation. Participants (n=120) will be adults interested in losing weight, body mass index (BMI)>30 kg/m2and smartphone users. The intervention group will use the app/website for 12 months. Participants will nominate one or more helpers to support them. Helpers have access to the app/website. The control group will receive a leaflet on healthy lifestyle and will have access to HelpMeDoIt! after follow-up. The key outcome of the study is whether prespecified progression criteria have been met in order to progress to a larger randomised controlled effectiveness trial. Data will be collected at baseline, 6 and 12 months. Outcomes focus on exploring the feasibility of delivering the intervention and include: (i) assessing three primary outcomes (BMI, physical activity and diet); (ii) secondary outcomes of waist/hip circumference, health-related quality of life, social support, self-efficacy, motivation and mental health; (iii) recruitment and retention; (iv) National Health Service (NHS) resource use and participant borne costs; (v) usability and acceptability of the app/website; and (vi) qualitative interviews with up to 50 participants and 20 helpers on their experiences of the intervention. Statistical analyses will focus on feasibility outcomes and provide initial estimates of intervention effects. Thematic analysis of qualitative interviews will assess implementation, acceptability, mechanisms of effect and contextual factors influencing the intervention.Ethics and disseminationThe protocol has been approved by the West of Scotland NHS Research Ethics Committee (Ref: 15/WS/0288) and the University of Glasgow MVLS College Ethics Committee (Ref: 200140108). Findings will be disseminated widely through peer-reviewed publication and conference presentations.Trial registration numberISRCTN85615983.


Author(s):  
Alberto Hernández-Reyes ◽  
Fernando Cámara-Martos ◽  
Guillermo Molina Recio ◽  
Rafael Molina-Luque ◽  
Manuel Romero-Saldaña ◽  
...  

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


2020 ◽  
Author(s):  
Eivind Andersen ◽  
Steinar Øvreås ◽  
Kari Anne Jørgensen ◽  
Janne Borch-Jenssen ◽  
Thomas Moser

Abstract Background: A growing body of evidence suggest that the children’s physical activity (PA) level in early childhood education and care (ECEC) settings are insufficient. Since most children attend ECEC settings for many hours on most days of the week, and these institutions reach children across the socioeconomic spectrum, the ECEC settings may serve as an ideal avenue for increasing physical activity level, reduce sedentary time and enhance the overall health of young children. This paper investigates the effectiveness of the “Active Kindergarten – Active Children” study to increase children’s PA level and reduce sedentary time within the ECEC setting. Methods: Accelerometers were used to asses PA and sedentary time. A total of 116 three to four-year olds took part in a randomised controlled trial in 11 ECEC settings. Participants were cluster-randomised, by ECEC setting, to either a 12 week staff-led and expert-supported intervention or a waiting list control group. Results: The intervention group increased time spent in moderate- and vigorous intensity PA by 10 min/day (95% CI = 3, 18; P=0.01), took 1909 more steps per day (95% CI = 1130, 2688; P˂0.01) and reduced sedentary time with 14min/day (95% CI = -27, -1; P=0.04) compared to the control group. The intervention group had a 2.4 higher odds (95% CI = 1.05, 5.7; P = 0.04) of meeting the PA recommendations compared to the control group at follow-up. Conclusions: Our results show that a flexible staff-led and expert-supported multicomponent PA intervention can increase total PA level, moderate- and vigorous intensity PA and reduce time spent sedentary in three to four-year old children during their stay in ECEC settings.Trial registration: The trial was retrospectively registered on September 19, 2020 and available online at ClinicalTrials.gov: No. NCT04555746


Author(s):  
Dr. Kavita Sreekumar ◽  
Miss Pallavi Nachinolkar ◽  
Dr. M.P. Silveira

Objective: To study if continuous temperature monitoring helps to prevent excessive postnatal weight loss in healthy newborns during hospital stay. Design: Prospective randomised controlled trial Setting: Postnatal ward of a tertiary level hospital in south-west India, between July 2018 and October 2018. Participants: 515 healthy newborns born in the hospital during the study. Intervention: Mothers were given the BEMPU device within 24 hours of delivery and  taught to recognize alarms and take measures to treat hypothermia when the device alarmed till the baby was discharged from the hospital. All healthy newborns born in the hospital were included in the study and random allocation was done to either the intervention or control group.  Babies who were sick and admitted in NICU and babies with congenital anomalies were excluded.  IEC approval was obtained prior to the study.  Outcome measures: postnatal weight loss. Results:  515 babies were included in the analysis.  For vaginal deliveries; 163 babies were in the intervention group and 168 were in the control group. The mean lowest weight was higher and the mean weight loss was lower for the intervention group. For caesarean deliveries, 91 babies were in the intervention and 93 were in the control groups. The mean lowest weight was higher and the mean weight loss was lower for the intervention group for cesarean deliveries as well. Conclusions: Continuous monitoring of the temperature helps to prevent excessive postnatal weight loss in healthy babies born by spontaneous vaginal deliveries. Keywords: Hypothermia, Newborn, Temperature, Weight loss


Spinal Cord ◽  
2020 ◽  
Author(s):  
Mohammad Sohrab Hossain ◽  
Lisa A. Harvey ◽  
Md. Shofiqul Islam ◽  
Md. Akhlasur Rahman ◽  
Stephen Muldoon ◽  
...  

Abstract Study design Randomised controlled trial. Objectives To determine the effectiveness of a sustainable community-based intervention designed to prevent serious complications and death 2 years after discharge in people with spinal cord injury in Bangladesh. Setting Bangladesh. Methods A pragmatic randomised controlled trial was undertaken. People who had sustained a spinal cord injury in the preceding 2 years, were wheelchair-dependent, and were about to be discharged from hospital in Bangladesh were recruited and randomised to an Intervention or Control group using a concealed allocation procedure stratified by level of lesion (tetraplegia/paraplegia). Participants in the Intervention group received 36 phone calls and three home visits over the first 2 years following discharge. All participants received usual post-discharge care. Survival status and date of death were determined by blinded assessors 2 years after randomisation. Results Between July 2015 and March 2018, 410 participants were randomised (204 to Intervention, 206 to Control). There was no loss to follow up. At 2 years, 15 (7.4%) participants in the Intervention group and 16 (7.8%) participants in the Control group had died (hazard ratio from unadjusted Cox model = 0.93 [95% CI, 0.46 to 1.89]; p from log rank test 0.85). There were no clinically important or statistically significant average causal effects of intervention on the incidence or severity of complications. Conclusion A program of community-based care for people with recent spinal cord injury in Bangladesh involving frequent phone contact and occasional in-person contact with a health professional after discharge from hospital is no better at preventing death at 2 years than usual care.


2018 ◽  
Vol 78 (2) ◽  
pp. 226-237 ◽  
Author(s):  
Susan L Dunn ◽  
Lorraine B Robbins ◽  
Sandi W Smith ◽  
Rajiv Ranganathan ◽  
Holli A DeVon ◽  
...  

Objective: Hopelessness is present in 27% of patients with ischaemic heart disease (IHD), can persist for 12 months and is associated with lack of physical activity (PA). No interventions have been tested to increase PA in IHD patients who report hopelessness. This study evaluated the feasibility of conducting a randomised controlled trial to investigate the effectiveness of the Heart Up! intervention, designed to reduce hopelessness through enhanced PA in IHD patients. It was hypothesised that increased PA would be identified in the intervention group. Setting: Patients were recruited from a large teaching hospital in the Midwestern USA. Data collection occurred in the patient’s home at 1 and 8 weeks after hospital discharge. Methods: A three-group design was used. Eligible patients were randomised to (1) motivational social support (MSS) from a nurse, (2) MSS from a nurse with social support from a significant other support (SOS) or (3) control. MSS-only and MSS-SOS recipients received motivational interviewing followed by 6 weeks of social support text messages from a nurse. MSS-SOS participants additionally received social support text messages from a significant other. Control participants received the usual care. Feasibility outcomes included recruitment and retention rates, patient acceptability and patient satisfaction. An accelerometer measured PA. Results: Of the 156 patients screened for the study, 43 met the inclusion criteria. Of eligible patients, 69.8% ( n = 30) enrolled and 67% ( n = 20) completed the study. Patients in the MSS and MSS-SOS groups expressed satisfaction with the intervention components (86% with motivational interviewing, 77% with nurse texts and 100% with significant other texts). Although differences were not statistically significant, a medium effect size for change in PA was identified in the MSS-SOS group compared to the other two groups. Conclusion: Study findings demonstrate the feasibility of the Heart Up! intervention and support testing its efficacy in a randomised controlled trial.


2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Eivind Andersen ◽  
Steinar Øvreås ◽  
Kari Anne Jørgensen ◽  
Janne Borch-Jenssen ◽  
Thomas Moser

Abstract Background A growing body of evidence suggest that the children’s physical activity (PA) level in early childhood education and care (ECEC) settings are insufficient. Since most children attend ECEC settings for many hours on most days of the week, and these institutions reach children across the socioeconomic spectrum, the ECEC settings may serve as an ideal avenue for increasing physical activity level, reduce sedentary time and enhance the overall health of young children. This paper investigates the effectiveness of the “Active Kindergarten – Active Children” study to increase children’s PA level and reduce sedentary time within the ECEC setting. Methods Accelerometers were used to asses PA and sedentary time. A total of 116 three to four-year olds took part in a randomised controlled trial in 11 ECEC settings. Participants were cluster-randomised, by ECEC setting, to either a 12 week staff-led and expert-supported intervention or a waiting list control group. Results The intervention group increased time spent in moderate- and vigorous intensity PA by 10 min/day (95% CI = 3, 18; P = 0.01), took 1909 more steps per day (95% CI = 1130, 2688; P < 0.01) and reduced sedentary time with 14 min/day (95% CI = − 27, − 1; P = 0.04) compared to the control group. The intervention group had a 2.4 higher odds (95% CI = 1.05, 5.7; P = 0.04) of meeting the PA recommendations compared to the control group at follow-up. Conclusions Our results show that a flexible staff-led and expert-supported multicomponent PA intervention can increase total PA level, moderate- and vigorous intensity PA and reduce time spent sedentary in three to four-year old children during their stay in ECEC settings. Trial registration The trial was retrospectively registered on September 19, 2020 and available online at ClinicalTrials.gov: No. NCT04555746.


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