Simplifying Diet Tracking in a Digital Weight Loss Intervention

N/ANot Yet RecruitingNCT07601061

Stanford University328 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

328

Conditions

Overweight Obesity Weight Loss

Interventions

Simplified Dietary Self-MonitoringBEHAVIORAL

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.

Detailed Dietary Self-MonitoringBEHAVIORAL

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.

Core Behavioral Weight Loss InterventionBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Weight Change from Baseline to 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)

Time frame: Baseline, 12 Months

Secondary Outcomes

Weight Change from Baseline to 1 Month

mean change in body weight (kg); assessed objectively via e-scale using standardized procedures

Time frame: Baseline, 1 Month

Weight Change from Baseline to 6 Months

mean change in body weight (kg); assessed objectively via e-scale using standardized procedures

Time frame: Baseline, 6 Months

Weight Change from Baseline to 18 Months

mean change in body weight (kg); assessed objectively via e-scale using standardized procedures

Time frame: Baseline, 18 Months

Caloric Intake Change from Baseline to 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

Time frame: Baseline, 12 Months

Diet Quality Change from Baseline to 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

Time frame: Baseline, 12 Months

Step Count Change from Baseline to 12 Months

mean change in step count; assessed objectively via activity tracker

Time frame: Baseline, 12 Months

Health-Related Quality of Life (Physical Health) Change from Baseline to 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

Time frame: Baseline, 12 Months

Health-Related Quality of Life (Mental Health) Change from Baseline to 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

Time frame: Baseline, 12 Months

Engagement in Self-Monitoring Dietary Intake

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

Time frame: daily during the 12-month intervention

Engagement in Self-Monitoring Weight

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

Time frame: daily during the 12-month intervention

Engagement in Self-Monitoring Steps

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

Time frame: daily during the 12-month intervention

Simplifying Diet Tracking in a Digital Weight Loss Intervention

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts