The goal of this study is to test multiple individual treatment components added to a 6-month standard mobile behavioral weight loss program that are intended to help participants follow dietary recommendations and meet their dietary goals more often. The four components to be studied include switching dietary tracking methods, receiving access to a goal planning tool, receiving additional personalized text messages, and receiving three sessions with a health coach. The study will identify the best combination of these additional treatments for improving total number of weeks in the program that participants meet their dietary goals.
BMI 25-50 kg/m2 at baseline
Own a smartphone with an active data and text messaging plan
English-speaking and writing
Willing to be randomized to any of the additional treatment components
Lost 5% or more of body weight (and kept it off) in the last 3 months
Past diagnosis of or receiving treatment for a clinically diagnosed eating disorder (anorexia nervosa or bulimia nervosa)
Current symptoms of alcohol or substance dependence
Currently pregnant, pregnant within the past 6 months, currently breastfeeding, or planning to become pregnant within the next 6 months
Factorial
Core
BehavioralBehavioral weight loss core includes daily self-monitoring (tracking) of dietary intake, physical activity, and weight; personalized daily goals for dietary intake and physical activity; weekly behavioral lessons in the study app; weekly tailored feedback on goal progress and weight change; 5-6 text messages per week.
Switch to Simplified Diet Monitoring
BehavioralSwitch from standard detailed calorie tracking to a simplified diet self-monitoring approach in which participants track red foods using a color-coded traffic light system.
Goal Autonomy/Planning
BehavioralA weekly goal planning tool that allows participants to adjust their dietary goals and make a specific plan for the week.
Just-in-time (JIT) Messaging
BehavioralIncreased frequency of text messages (1-2 per day), highly personalized based on past and current dietary adherence and weight change.
Coach Sessions
BehavioralReceive 3 brief telephone or video coach sessions (20-30 minutes) every other week following randomization.
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Treatment groupsSee each treatment group below.
Total weeks of dietary goal adherence
Objective self-monitoring of dietary intake (pulled via the Fitbit API for those in the conditions with standard dietary self-monitoring and the Traffic Light Log app API for the those in conditions that switch to simplified dietary self-monitoring) will be used to calculate, among nonresponders randomized into the factorial trial, number of days after randomization in which the dietary goal (calorie goal or red food goal) was met ≥ 3 days/week (the daily dietary goal is defined as a complete day of tracking and ≤ the calorie/red food goal).
Percent of participants reaching >= 5% weight loss
Scale weights at baseline and 6 months will be used to calculate, among nonresponders randomized into the factorial trial, percent weight change ( \[(weight at 6 months - baseline weight) / baseline weight\] × 100) and classify participants as achieving or not achieving at least 5% weight loss.
Total days of dietary goal adherence
Objective self-monitoring of dietary intake (pulled via the Fitbit API for those in the conditions with standard dietary self-monitoring and the Traffic Light Log app API for the those in conditions that switch to simplified dietary self-monitoring) will be used to calculate, among nonresponders randomized into the factorial trial, number of days after randomization in which the dietary goal (calorie goal or red food goal) was met (the daily dietary goal is defined as a complete day of tracking and ≤ the calorie/red food goal).
Weight Change (kg)
Estimated mean weight change in kg from baseline to 6 months among nonresponders randomized into the factorial trial. More negative values of weight change indicate greater weight loss. Weights will be objectively measured in light clothes, without shoes, on the digital smart scales in participants' homes.
Dietary intake
Diet will be assessed using the self-administered National Cancer Institute's Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool, a free, web-based tool for 24-hour recalls. Participants will complete unscheduled recalls on a weekday and a weekend day at each timepoint. Change in average total kcals/day will be calculated among nonresponders randomized into the factorial trial. Changes are calculated as (average daily kcal at 3/6 months - average daily kcal at baseline).
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UNC Lineberger Comprehensive Cancer Center
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
