An addiction-based mobile health weight loss intervention: protocol of a randomized controlled trial.
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ABSTRACT: Background
The notion of obesity as an addictive process is controversial. However, studies show that between 5.9 and 30.7% of adolescents with obesity report food or eating addiction. Few weight management interventions have tested techniques based on addiction medicine principles.Methods
This multi-center randomized control trial (RCT) is designed to test the effectiveness of a mobile health (mHealth) weight-loss intervention based on addiction principles, such as withdrawal and tolerance, in a sample of 180 adolescents (ages 14-18) recruited from four pediatric weight management clinics in Southern California. Akin to a Multiphase Optimization Strategy (MOST) design evaluating multicomponent behavioral interventions, we will compare the combination of an app + phone coaching (App+Coach) to app alone (App) and in-clinic multi-disciplinary (Clinic) intervention arms. The primary outcome is mean change in zBMI and %BMIp95 over 18 months. We hypothesize that youth who receive App+Coach will have a greater reduction in body weight over the 18-month study period at a lower cost than standard of care models. Secondary outcomes include adherence to treatment regimen, intervention satisfaction, effect of the intervention on metabolic factors and activity level. We will also explore potential moderators of intervention effectiveness such as addictive eating habits, self-regulation and executive functioning.Conclusions
New and creative approaches are needed to address pediatric obesity. If successful, this RCT may provide an innovative and cost-effective mHealth approach, based on addiction methods, for weight loss among adolescents with overweight and obesity.
SUBMITTER: Vidmar AP
PROVIDER: S-EPMC8078064 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectiveThis randomized clinical trial tested the effectiveness of an addiction-based digital weight-loss intervention, focusing on withdrawal/abstinence from self-identified problem foods, snacking and excessive amounts at meals, and discomfort displacement, with and without coaching, compared to an in-person, multi-disciplinary, care model among adolescents with obesity. We hypothesized that the digital intervention with coaching would yield greater weight loss and lower delivery burden than the standard clinical arm, and greater participant engagement than the digital arm without coaching.MethodsAdolescents were randomized to app intervention, with or without coaching, or in-person multidisciplinary obesity intervention for 6 months. The primary outcome was change in %BMIp95 at weeks 12 and 24. A mixed-effects linear regression model was used to assess the association between change in %BMIp95 and intervention arm. We were also interested in assessing delivery burden, participant engagement and evaluating the relationships between weight change and demographic characteristics, mood, executive function and eating behaviours.ResultsAll adolescents (n = 161; BMI ≥95th%, age 16 ± 2.5 year; 47% Hispanic, 65% female, 59% publicly insured) lost weight over 24-weeks (-1.29%, [-1.82, -0.76], p < 0.0001), with no significant weight loss difference between groups (p = 0.3). Girls lost more weight than boys, whereas binge eating behaviour at baseline was associated with increase in %BMIp95 when controlling for other covariates. There was no association between ethnicity, mood, timing of intervention in relation to the pandemic, or executive function and change in %BMIp95 .ConclusionsContrary with our hypothesis, our results showed no difference in the change in BMI status between treatment arms. Since efficacy of this digital intervention was not inferior to in-person, multi-disciplinary care, this could offer a reasonable weight management option for clinicians, based on youth and family specific characteristics, such as accessibility, resources, and communication styles.Clinical trial registrationClinicalTrials.gov identifier: NCT035008353.
| S-EPMC9905275 | biostudies-literature
Project description:BackgroundClinical approaches to treating childhood obesity can be expensive and poorly reimbursed, and often produce suboptimal results. It has been theorized that overeating may have addictive qualities, and a sizable number of adolescents with obesity endorse addictive habits. Interestingly, few weight management interventions have tested techniques founded in addiction medicine principles. We therefore performed a pilot study of an addiction model based mHealth weight loss intervention in adolescents.MethodsAdolescents with obesity were recruited from an multidisciplinary weight management clinic (EMPOWER). Adolescents without significant obesity comorbidities, who exhibited signs of addictive eating, based on the Yale Food Addiction Scale, were enrolled in a pilot study of an interactive, addiction-based, weight loss smartphone app with coaching (http://clinicaltrials.gov: NCT02689154). The app was designed to help subjects omit problem foods, avoid snacking and reduce meal size. A contemporary cohort of adolescents who completed the EMPOWER program were evaluated. Feasibility of recruitment, adherence, retention rates, BMI change and cost of intervention were examined.ResultsEighteen participants were recruited to app intervention. App participants had higher retention (100% vs. 37%) and lower total cost per patient ($855.15 vs. $1428.00) than the EMPOWER clinic participants. App participants exhibited a significant decrease in zBMI and %BMIp95 over the 6 months (p < 0.001 and p = 0.001), which was comparable to the age-matched EMPOWER program completers (p = 0.31 and p = 0.06).ConclusionsAn addiction medicine-based mHealth intervention targeted for adolescents was feasible to implement, resulted in high retention and adherence rates, and reduced zBMI and %BMIp95 in a more cost-effective manner than an in-clinic intervention.
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Project description:IntroductionMen who are overweight or obese in the rural Midwestern USA are an unrepresented, at-risk group exhibiting rising rates of cardiovascular disease, poor access to preventive care and poor lifestyle behaviours that contribute to sedentary lifestyle and unhealthy diet. Self-monitoring of eating and activity has demonstrated efficacy for weight loss. Use of mobile technologies for self-monitoring eating and activity may address rural men's access disparities to preventive health resources and support weight loss. Our pilot trial will assess the feasibility and acceptability of two mobile applications for weight loss in rural men to inform a future, full-scale trial.Methods and analysisA 6-month randomised controlled trial with contextual evaluation will randomise 80 men using a 1:1 ratio to either a Mobile Technology Plus (MT+) intervention or a basic Mobile Technology (MT) intervention in rural, midlife men (aged 40-69 years). The MT+ intervention consists of a smartphone self-monitoring application enhanced with discussion group (Lose-It premium), short message service text-based support and Wi-Fi scale. The MT group will receive only a self-monitoring application (Lose-It basic). Feasibility and acceptability will be evaluated using number of men recruited and retained, and evaluative focus group feedback. We seek to determine point estimates and variability of outcome measures of weight loss (kg and % body weight) and improved dietary and physical activity behaviours (Behavioral Risk Factor Surveillance System (BRFSS) physical activity and fruit and vegetable consumption surveys, data from Lose-It! application (kcal/day, steps/day)). Community capacity will be assessed using standard best practice methods. Descriptive content analysis will evaluate intervention acceptability and contextual sensitivity.Ethics and disseminationThis protocol was approved by the University of Nebraska Medical Center Institutional Review Board (IRB# 594-17-EP). Dissemination of findings will occur through ClinicalTrials.gov and publish pilot data to inform the design of a larger clinical trial.Trial registration numberNCT03329079; preresults. Protocol V.10, study completion date 31 August 2020. Roles and responsibilities funder: NIH/NINR Health Disparities Section 1R15NR017522-01.
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Project description:IntroductionDigital behavioural weight loss interventions have the potential to improve public health; however, these interventions are often not adequately tailored to the needs of the participants. This is the protocol for a trial that aims to determine the effectiveness and cost-effectiveness of the Choosing Health programme as a means to promote weight loss and weight loss maintenance among overweight/obese adults.Methods and analysisThe proposed study is a two-group randomised controlled trial with a nested interrupted time series (ITS) within-person design. Participants (n=285) will be randomly assigned to either the Choosing Health digital intervention or a control group. For intervention participants, ecological momentary assessment will be used to identify behavioural determinants for each individual in order to tailor evidence-based behaviour change techniques and intervention content.Control group participants will receive non-tailored weight loss advice via e-book and generic emails. The primary outcome is the mean difference in weight loss between groups at 6 months controlled for baseline. Secondary outcomes include blood pressure and percentage of body fat; self-reported measures of physical activity, sitting time, quality of life, cost and theory-derived correlates of weight loss. Secondary outcomes will be measured at baseline, 3, 6 and 12 months. The primary outcome for ITS will be daily weight loss plan adherence. Data will be analysed using regression and time series analyses.Ethics and disseminationEthics approval was granted by Faculty of Psychology, SWPS University of Social Sciences and Humanities, Wroclaw, Poland, approval number 03/P/12/2019. The project results will be disseminated through structured strategy implemented in collaboration with the Ministry of Health.Trial registration detailsThis trial was registered with www.clinicaltrials.gov; registration number NCT04291482.
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Project description:Early adolescents diagnosed with asthma have difficulties consistently performing disease self-management behaviors, placing them at-risk for poor asthma control, morbidity, and reduced quality of life. Helpful caregiver support is pivotal in determining whether early adolescents develop and master asthma self-management behaviors. We developed Applying Interactive Mobile health to Asthma Care in Teens (AIM2ACT), a mobile health intervention to facilitate helpful caregiver support in early adolescents (12-15 year-olds) with poorly controlled asthma. AIM2ACT is a dyadic smartphone intervention that contains three components: 1) ecological momentary assessment to identify personalized strengths and weaknesses in asthma self-management behaviors; 2) collaborative identification and tracking of goals that help early adolescents to become increasingly independent in managing their asthma; and 3) a suite of skills training videos. This paper describes our plans to test the efficacy of AIM2ACT and evaluate long-term maintenance of treatment effects in a fully powered randomized controlled trial with 160 early adolescents with poorly controlled persistent asthma, ages 12-15 years, and a caregiver. Families will be randomly assigned to receive AIM2ACT (n = 80) or a mHealth attention control condition (n = 80) that accounts for attention and novelty of a technology-based intervention for 6 months. Assessments will occur at baseline, post-intervention, and 3-, 6-, and 12-month follow-up time points. We will collect patient-reported and objectively monitored (e.g., spirometry, adherence) outcomes. Given the timing of the trial, a secondary exploratory goal is to evaluate the perceived impact of COVID-19 on family functioning and parental control of their adolescent's asthma in the context of our intervention.
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Project description:OBJECTIVE:The objective of this study was to test whether behavioral weight loss (BWL) intervention decreases headaches in women with comorbid migraine and overweight or obesity. METHODS:This randomized, single-blind trial allocated women 18 to 50 years old with 4 to 20 migraine days per month and a BMI?=?25.0-49.9?kg/m2 to 16 weeks of BWL (n?=?54), which targeted exercise and eating behaviors for weight loss, or to migraine education control (ME, n?=?56), which delivered didactic instruction on migraine and treatments. Participants completed a 4-week smartphone headache diary at baseline, posttreatment (16-20 wk), and follow-up (32-36 wk). The primary outcome was posttreatment change in migraine days per month, analyzed via linear mixed effects models. RESULTS:Of 110 participants randomly assigned, 85 (78%) and 80 (73%) completed posttreatment and follow-up. Although the BWL group achieved greater weight loss (mean [95% CI] in kilograms) than the ME group at posttreatment (-3.8 [-2.5 to -5.0] vs.?+?0.9 [-0.4 to 2.2], P?<?0.001) and follow-up (-3.2 [-2.0 to -4.5] vs.?+?1.1 [-0.2 to 2.4], P?<?0.001), there were no significant group (BWL vs. ME) differences (mean [95% CI]) in migraine days per month at posttreatment (-3.0 [-2.0 to -4.0] vs. -4.0 [-2.9 to -5.0], P?=?0.185) or follow-up (-3.8 [-2.7 to -4.8] vs. -4.4 [-3.4 to -5.5], P?=?0.378). CONCLUSIONS:Contrary to hypotheses, BWL and ME yielded similar, sustained reductions in migraine headaches. Future research should evaluate whether adding BWL to standard pharmacological and/or nonpharmacological migraine treatment approaches yields greater benefits.
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Project description:ObjectiveTo determine the effect on weight of two mobile technology-based (mHealth) behavioral weight loss interventions in young adults.MethodsRandomized, controlled comparative effectiveness trial in 18- to 35-year-olds with BMI ≥ 25 kg/m(2) (overweight/obese), with participants randomized to 24 months of mHealth intervention delivered by interactive smartphone application on a cell phone (CP); personal coaching enhanced by smartphone self-monitoring (PC); or Control.ResultsThe 365 randomized participants had mean baseline BMI of 35 kg/m(2) . Final weight was measured in 86% of participants. CP was not superior to Control at any measurement point. PC participants lost significantly more weight than Controls at 6 months (net effect -1.92 kg [CI -3.17, -0.67], P = 0.003), but not at 12 and 24 months.ConclusionsDespite high intervention engagement and study retention, the inclusion of behavioral principles and tools in both interventions, and weight loss in all treatment groups, CP did not lead to weight loss, and PC did not lead to sustained weight loss relative to Control. Although mHealth solutions offer broad dissemination and scalability, the CITY results sound a cautionary note concerning intervention delivery by mobile applications. Effective intervention may require the efficiency of mobile technology, the social support and human interaction of personal coaching, and an adaptive approach to intervention design.
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Project description:To our knowledge, no studies have evaluated whether weight loss can be promoted in overweight adults through the use of an intervention that is largely based on daily SMS (Short Message Service: text) and MMS (Multimedia Message Service: small picture) messages transmitted via mobile phones.This paper describes the development and evaluation of a text message-based intervention designed to help individuals lose or maintain weight over 4 months.The study was a randomized controlled trial, with participants being exposed to one of the following two conditions, lasting 16 weeks: (1) receipt of monthly printed materials about weight control; (2) an intervention that included personalized SMS and MMS messages sent two to five times daily, printed materials, and brief monthly phone calls from a health counselor. The primary outcome was weight at the end of the intervention. A mixed-model repeated-measures analysis compared the effect of the intervention group to the comparison group on weight status over the 4-month intervention period. Analysis of covariance (ANCOVA) models examined weight change between baseline and 4 months after adjusting for baseline weight, sex, and age.A total of 75 overweight men and women were randomized into one of the two groups, and 65 signed the consent form, completed the baseline questionnaire, and were included in the analysis. At the end of 4 months, the intervention group (n = 33) lost more weight than the comparison group (-1.97 kg difference, 95% CI -0.34 to -3.60 kg, P = .02) after adjusting for sex and age. Intervention participants' adjusted average weight loss was 2.88 kg (3.16%). At the end of the study, 22 of 24 (92%) intervention participants stated that they would recommend the intervention for weight control to friends and family.Text messages might prove to be a productive channel of communication to promote behaviors that support weight loss in overweight adults.
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Project description: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.
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Project description:Interventions delivered by mobile devices (mHealth interventions) have the potential to increase access to weight management treatment in low-income populations. However, little prior research has examined effects of mHealth programming plus phone-based community health worker (CHW) support for weight management among public housing residents. For our intervention, we first interacted with a community advisory board to collect feedback on proposed intervention components. Transcripts from 5 advisory board meetings were coded and qualitative data was organized into themes. We used these data to inform our ongoing trial, in which public housing residents are randomized to one of three different groups: phone text messaging and digital self-weighing (mHealth only); mHealth intervention plus CHW behavioral phone counseling (mHealth+CHW); or assessment only to evaluate their differential effects on weight loss at 6- and 12-month follow-up. We will examine changes in diet and physical activity behaviors as well as potential mediating and moderating factors. Results of this trial could provide support for technology-based weight management interventions which may have greater potential for scalability and long-term dissemination than face-to-face programming. Clinical Trial Registration Number: NCT04852042.
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