scholarly journals A Pilot Randomized Controlled Trial of a Telenutrition Weight Loss Intervention in Middle-Aged and Older Men with Multiple Risk Factors for Cardiovascular Disease

Nutrients ◽  
2019 ◽  
Vol 11 (2) ◽  
pp. 229 ◽  
Author(s):  
Melissa Ventura Marra ◽  
Christa Lilly ◽  
Kelly Nelson ◽  
Dominick Woofter ◽  
James Malone

Overweight and obesity threaten the health, functionality and quality of life of 77.2% men in West Virginia. The purpose of this study was to evaluate the feasibility and effectiveness of a 12-week primary care referred telenutrition weight loss intervention. Fifty-nine 40–70-year-old men with obesity were randomized to either the intervention group (n = 29) or an enhanced usual care (EUC) (n = 30) group. Participants from both groups were prescribed a moderate energy restricted diet (500–750 kcal/day below energy requirements) and provided diet-related educational materials; but, only those in the intervention group received weekly support from a registered dietitian nutritionist via telephone and videoconferencing. Both groups significantly reduced body weight, waist circumference, percent body fat and caloric intake and improved diet quality from baseline (p < 0.0001). Groups did not differ after controlling for time (all p > 0.30) and none of the group by time interactions were statistically significant. At week 12, a greater proportion of participants from the intervention group than the EUC group lost at least 5% of their baseline weight, (70.4% vs. 41.4%, p = 0.035). Retention rates and participant-reported adherence and satisfaction rates were ≥80% in the telenutrition group, thereby meeting the a priori criterion for feasibility of a larger trial. Primary care referred telenutrition interventions have the potential to improve access to dietary counseling for obesity treatment in health disparate populations. A larger longer-term trial is warranted.

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 ◽  
2020 ◽  
Vol 10 (7) ◽  
pp. e035720
Author(s):  
Margaret E Wright ◽  
Emerson Delacroix ◽  
Kendrin R Sonneville ◽  
Shannon Considine ◽  
Tim Proctor ◽  
...  

IntroductionPrimary care remains an underused venue for prevention and management of paediatric overweight and obesity. A prior trial demonstrated a significant impact of paediatrician/nurse practitioner (Ped/NP)-and registered dietitian (RD)-delivered motivational interviewing (MI) on child body mass index (BMI). The study described here will test the effectiveness of an enhanced version of this primary care-based MI counselling intervention on child BMI.Methods and analysisThis cluster randomised effectiveness trial includes 24 Ped/NPs from 18 paediatric primary care practices that belong to the American Academy of Pediatrics (AAP) national Pediatric Research in Office Settings (PROS) practice-based research network. To date, practices have been randomised (nine to intervention and nine to usual care). Intervention Ped/NPs have been trained in MI, behavioural therapy, billing/coding for weight management and study procedures. Usual care Ped/NPs received training in billing/coding and study procedures only. Children 3– 11 years old with BMI >the 85th percentile were identified via electronic health records (EHRs). Parents from intervention practices have been recruited and enrolled. Over about 2 years, these parents are offered approximately 10 MI-based counselling sessions (about four in person sessions with their child’s Ped/NP and up to six telephonic sessions with a trained RD). The primary outcome is change in child BMI (defined as per cent from median BMI for age and sex) over the study period. The primary comparison is between eligible children in intervention practices whose parents enrol in the study and all eligible children in usual care practices. Data sources will include EHRs, billing records, surveys and counselling call notes.Ethics and disseminationInstitutional Review Board approval was obtained from the AAP. All Ped/NPs provided written informed consent, and intervention group parents provided consent and Health Insurance Portability and Accountability Act (HIPAA) authorisation. Findings will be disseminated through peer-reviewed publications, conference presentations and appropriate AAP channels.Trial registration numberNCT03177148; Pre-results.


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.


10.2196/22147 ◽  
2021 ◽  
Vol 9 (3) ◽  
pp. e22147
Author(s):  
Karen Lim ◽  
Shiao-Yng Chan ◽  
Su Lin Lim ◽  
Bee Choo Tai ◽  
Cammy Tsai ◽  
...  

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


BMJ Open ◽  
2018 ◽  
Vol 8 (10) ◽  
pp. e022663 ◽  
Author(s):  
Eleanor Quested ◽  
Dominika Kwasnicka ◽  
Cecilie Thøgersen-Ntoumani ◽  
Daniel F Gucciardi ◽  
Deborah A Kerr ◽  
...  

IntroductionOverweight and obesity are highly prevalent among Australian men. Professional sports settings can act as a powerful ‘hook’ to engage men in weight loss programmes; the Football Fans in Training programme delivered in professional UK soccer clubs was successful and cost-effective in helping men lose weight. The Australian Football League (AFL) is a potentially attractive setting to engage men in a weight loss programme. We aim to develop, pilot and evaluate the feasibility of a weight loss intervention for overweight/obese middle-aged men, delivered in AFL settings, to promote weight loss and healthier lifestyles and determine its suitability for a future randomised control trial.Methods and analysis120 overweight/obese male fans will complete baseline physical and psychological health measures and objective measures of physical activity (PA), weight, waist size and blood pressure prior to randomisation into the intervention or waitlist comparison group. The intervention group will receive 12 weekly 90 min workshops incorporating PA, nutrition education, behaviour change techniques and principles of effective motivation. Four community coaches will be trained to deliver Aussie-FIT at two AFL clubs in Western Australia. Measurements will be repeated in both groups at 3 months (post-intervention) and 6 months (follow-up). Outcomes will include programme uptake, attendance, changes in lifestyle and weight variables to inform power calculations for a future definitive trial, fidelity of programme delivery, acceptability, satisfaction with the programme and perceptions of effectiveness. We will also determine trial feasibility and potential to gather cost-effectiveness data.Ethics and disseminationEthics approval was granted by Curtin University’s Human Research Ethics Committee (HREC2017-0458). Results will be disseminated via peer-reviewed publications, conference presentations and reports. A multicomponent dissemination strategy will include targeted translation and stakeholder engagement events to establish strategies for sustainability and policy change.Trial registration numberACTRN12617000515392; Pre-results.


2019 ◽  
Vol 46 (5) ◽  
pp. 763-772 ◽  
Author(s):  
David O. Garcia ◽  
Luis A. Valdez ◽  
Benjamin Aceves ◽  
Melanie L. Bell ◽  
Kyle Humphrey ◽  
...  

Background. Hispanic males have the highest rates of overweight and obesity compared with men of all other racial/ethnic groups. While weight loss can significantly reduce obesity-related health risks, there is limited research examining effective gender- and culturally tailored behavioral weight loss programs for Hispanic men. Objective. To assess the feasibility and preliminary efficacy of a 12-week gender- and culturally sensitive weight loss intervention (GCSWLI) as compared with a waist-list control (WLC) in sedentary, Hispanic males with overweight/obesity. Method. Fifty Hispanic males (age: 43 years [ SD = 11]; BMI: 34 ± 5 kg/m2; 58% Spanish monolingual) were randomized to one of two groups: GCSWLI ( n = 25) or WLC ( n = 25). GCSWLI participants attended weekly in-person individual sessions with a bilingual, bicultural Hispanic male lifestyle coach, and were prescribed a daily reduced calorie goal and 225 minutes of moderate-intensity physical activity per week. The WLC were asked to maintain their usual diet and physical activity habits for 12 weeks. GCSWLI participants continued with 12 additional weeks of follow-up including biweekly phone calls with lifestyle coaches. Results. At Week 12, the mean weight loss in the GCSWLI was −6.3 kg (95% confidence interval [CI; −8.1, −4.4]) compared with −0.8 kg (95% CI [−2.5, 0.9]) for the WLC (difference = −5.5 kg, 95% CI [−8.0, −2.9], p < .01). At Week 24, weight loss in the GCSWLI was maintained. Conclusions. The GCSWLI appears to be a feasible strategy to engage Hispanic males in short-term weight loss. Our pilot study indicates preliminary evidence of efficacy, though confirmation of these findings is needed in a larger study.


2020 ◽  
Author(s):  
Karen Lim ◽  
Shiao-Yng Chan ◽  
Su Lin Lim ◽  
Bee Choo Tai ◽  
Cammy Tsai ◽  
...  

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/m<sup>2</sup> or weight loss of at least 5% from first trimester weight if first trimester BMI&gt;23 kg/m<sup>2</sup>) 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 (<i>P</i>=.27). Compared with the control group, women in the intervention group reported significantly reduced caloric intake at 4 months after delivery (<i>P</i>&lt;.001) and higher health-directed behavior scores (<i>P</i>=.045). The intervention group also reported increased emotional distress scores (<i>P</i>=.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. CLINICALTRIAL ClinicalTrials.gov NCT03324737; https://clinicaltrials.gov/ct2/show/NCT03324737 INTERNATIONAL REGISTERED REPORT RR2-10.1186/s12889-019-7691-3


2016 ◽  
Vol 18 (2) ◽  
pp. 245-252 ◽  
Author(s):  
Elizabeth Holdsworth ◽  
Nicki Thorogood ◽  
Annik Sorhaindo ◽  
Kiran Nanchahal

Background. Overweight and obesity are major public health problems and an increasing global challenge. In lieu of wider policy changes to tackle the obesogenic environment in which we presently reside, improving the design of individual-level weight loss interventions is important. Aim. To identify which aspects of the Camden Weight Loss randomized controlled trial weight loss intervention participants engaged with, with the aim of improving the design of future studies and maximizing retention. Method. A qualitative study comprising semistructured interviews ( n = 18) and a focus group ( n = 5) with intervention participants. Results. Two important aspects of participant engagement with the intervention consistently emerged from interviews and focus group: the advisor–participant relationship and the program structure. Some materials used during the program sessions were important in supporting the intervention; however, others were not well received by participants. Conclusion. An individual-level weight loss intervention should be acceptable from the patient perspective in order to ensure participants are engaged with the program for as long as possible to maximize favorable results. Providing ongoing support in a long-term program with a trained empathetic advisor may be effective at engaging with people trying to lose weight in a weight loss intervention.


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