Health Behavior, Lifestyle Intervention, Obesity, Overweight, Weight Loss
Conditions
Keywords
digital intervention, behavioral intervention, behavior change, obesity, body weight, overweight, BMI, diet, tracking, track, self-monitoring, self-monitor, lifestyle, adults, intervention, weight loss, weight loss intervention, weight reduction, weight management, red zone foods, calorie counting, noninferiority trial, non-inferiority, comparative effectiveness trial, comparative effectiveness, RCT, randomized clinical trial, digital health, mobile health, obesity treatment, obesity management, remote intervention, standalone intervention, standalone
Brief summary
The purpose of this study is to compare two approaches for tracking dietary intake in a 12-month fully digital weight loss intervention: (1) Simplified approach: track Red Zone Foods (e.g., foods high in calories and low in nutritional value) vs. (2) Detailed approach: track all foods and their corresponding calories. In essence, this is a head-to-head comparison of two tracking approaches; the investigators are evaluating whether weight loss is comparable over 12 months, or whether one approach will have greater weight loss. The investigators will recruit 328 adults. Broadly, adults with overweight or obesity who live in the United States will be eligible. The weight loss intervention will last 12 months. All participants will be asked to track their dietary intake + body weight + steps daily as well as complete weekly behavioral lessons and action plans to promote healthy eating and physical activity. All study tasks will occur remotely. Assessment of body weight and survey measures will occur at the beginning of the trial ("baseline"), and at 1, 6, 12, and 18 months.
Interventions
BEHAVIORALSimplified Dietary Self-Monitoring
Participants randomized to receive this intervention are instructed to track their Red Zone Foods (i.e., foods high in calories and low in nutritional value) daily via a web-based checklist. Participants receive a daily Red Zone Food goal.
BEHAVIORALDetailed Dietary Self-Monitoring
Participants randomized to receive this intervention are instructed to track all foods/drinks and their corresponding calories daily via a mobile app. Participants receive a daily calorie goal.
BEHAVIORALCore Behavioral Weight Loss Intervention
All participants receive a 12-month core behavioral weight loss intervention consisting of the following: goal setting; daily self-monitoring of body weight \& steps; weekly behavioral lessons and action plans to promote healthy eating and physical activity; and tailored feedback. The intervention will be delivered remotely via email and/or text message.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
This study is a two-arm, noninferiority trial that randomizes participants to either the Simplified or Detailed arm using a 1:1 allocation. The trial is powered to evaluate noninferiority between these two self-monitoring approaches for the primary outcome of 12-month weight change. Noninferiority is met if the upper limit of the confidence interval for the between-arm difference in weight change is below a 2.5 kg margin. If noninferiority is met, we will test for superiority.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adults (ages 18+ years) * body mass index (BMI) 25.0 to 45.0 kg/m\^2 * smartphone ownership * willing to install a mobile app on personal smartphone * access to a personal email account * English or Spanish language proficiency * interest in losing weight through behavioral strategies * living in the United States * willing to be randomized
Exclusion criteria
* concurrent enrollment in another weight management intervention * loss of ≥5% weight in the past 6 months * prior or planned bariatric surgery during the trial period * current or planned pregnancy during the trial period, or recent pregnancy in the past 6 months * currently breastfeeding or lactating * current use of anti-obesity medications * living with someone else participating in the study * hospitalization for a mental health condition in the past 12 months * inability to engage in moderate forms of physical activity akin to brisk walking * medical or psychiatric contraindication (e.g., end stage renal disease, cancer, schizophrenia, dementia, use of steroids, use of antipsychotic medication) * if an individual would be better suited for a more intensive or different type of intervention based on a health condition (e.g., individuals with history of an eating disorder or cardiovascular event, uncontrolled hypertension, or uncontrolled diabetes mellitus) * investigator discretion for safety reasons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Change from Baseline to 12 Months | Baseline, 12 Months | mean change in body weight (kg); assessed objectively via e-scale using standardized procedures (e.g., place the scale on a hard surface; collect weight in the morning, without clothing, prior to eating/drinking) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight Change from Baseline to 1 Month | Baseline, 1 Month | mean change in body weight (kg); assessed objectively via e-scale using standardized procedures |
| Weight Change from Baseline to 6 Months | Baseline, 6 Months | mean change in body weight (kg); assessed objectively via e-scale using standardized procedures |
| Weight Change from Baseline to 18 Months | Baseline, 18 Months | mean change in body weight (kg); assessed objectively via e-scale using standardized procedures |
| Caloric Intake Change from Baseline to 12 Months | Baseline, 12 Months | mean change in daily caloric intake (kilocalories); assessed via the Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24): 2 separate diet recalls per time point: 1 week day, 1 weekend day |
| Diet Quality Change from Baseline to 12 Months | Baseline, 12 Months | mean change in diet quality; assessed via the Healthy Eating Index, calculated from ASA24 data; score range: 0 to 100, with higher scores indicating better diet quality |
| Step Count Change from Baseline to 12 Months | Baseline, 12 Months | mean change in step count; assessed objectively via activity tracker |
| Health-Related Quality of Life (Physical Health) Change from Baseline to 12 Months | Baseline, 12 Months | mean change in health-related quality of life (Physical Component Summary); assessed via the SF-36 survey; score range: 0 to 100, with higher scores indicating better quality of life |
| Health-Related Quality of Life (Mental Health) Change from Baseline to 12 Months | Baseline, 12 Months | mean change in health-related quality of life (Mental Component Summary); assessed via the SF-36 survey; score range: 0 to 100, with higher scores indicating better quality of life |
| Engagement in Self-Monitoring Dietary Intake | daily during the 12-month intervention | operationalized as average percentage of days in the 12-month intervention of self-monitoring dietary intake (Red Zone Foods for Simplified arm vs. all foods/calories for Detailed arm); assessed via e-checklist for Simplified arm and via app for Detailed arm; will report median (IQR) if data are non-normally distributed |
| Engagement in Self-Monitoring Weight | daily during the 12-month intervention | operationalized as average percentage of days in the 12-month intervention of self-monitoring body weight; assessed via e-scale; will report median (IQR) if data are non-normally distributed |
| Engagement in Self-Monitoring Steps | daily during the 12-month intervention | operationalized as average percentage of days in the 12-month intervention of self-monitoring steps; assessed via activity tracker; will report median (IQR) if data are non-normally distributed |
Countries
United States
Contacts
CONTACTStudy Team
PRINCIPAL_INVESTIGATORMichele L. Patel, PhD
Stanford University
Outcome results
None listed