Optimization of Dietary Adherence in a Mobile Weight Loss Intervention
Optimizing Dietary Adherence in a Mobile Behavioral Weight Loss Intervention for Adults
2 other identifiers
interventional
580
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2027
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2026
CompletedFirst Posted
Study publicly available on registry
May 13, 2026
CompletedStudy Start
First participant enrolled
March 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2029
Study Completion
Last participant's last visit for all outcomes
October 1, 2029
May 15, 2026
May 1, 2026
2.5 years
May 6, 2026
May 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Time of randomization to 6 months
Secondary Outcomes (4)
Percent of participants reaching >= 5% weight loss
Baseline to 6 months
Total days of dietary goal adherence
Time of randomization to 6 months
Weight Change (kg)
Baseline, 6 months
Dietary intake
Baseline, 3 months, 6 months
Study Arms (17)
Condition 1
EXPERIMENTALCore + Switch to Simplified Diet Monitoring + Goal Autonomy/Planning + Just-in-time (JIT) Messaging + Coach Sessions
Condition 2
EXPERIMENTALCore + Switch to Simplified Diet Monitoring + Goal Autonomy/Planning + Just-in-time (JIT) Messaging
Condition 3
EXPERIMENTALCore + Switch to Simplified Diet Monitoring + Goal Autonomy/Planning + Coach Sessions
Condition 4
EXPERIMENTALCore + Switch to Simplified Diet Monitoring + Goal Autonomy/Planning
Condition 5
EXPERIMENTALCore + Switch to Simplified Diet Monitoring + Just-in-time (JIT) Messaging + Coach Sessions
Condition 6
EXPERIMENTALCore + Switch to Simplified Diet Monitoring + Just-in-time (JIT) Messaging
Condition 7
EXPERIMENTALCore + Switch to Simplified Diet Monitoring + Coach Sessions
Condition 8
EXPERIMENTALCore + Switch to Simplified Diet Monitoring
Condition 9
EXPERIMENTALCore with Standard Diet Monitoring + Goal Autonomy/Planning + Just-in-time (JIT) Messaging + Coach Sessions
Condition 10
EXPERIMENTALCore with Standard Diet Monitoring + Goal Autonomy/Planning + Just-in-time (JIT) Messaging
Condition 11
EXPERIMENTALCore with Standard Diet Monitoring + Goal Autonomy/Planning + Coach Sessions
Condition 12
EXPERIMENTALCore with Standard Diet Monitoring + Goal Autonomy/Planning
Condition 13
EXPERIMENTALCore with Standard Diet Monitoring + Just-in-time (JIT) Messaging + Coach Sessions
Condition 14
EXPERIMENTALCore with Standard Diet Monitoring + Just-in-time (JIT) Messaging
Condition 15
EXPERIMENTALCore with Standard Diet Monitoring + Coach Sessions
Condition 16
EXPERIMENTALCore with Standard Diet Monitoring
Core Only (Responders)
OTHERCore program (participants who are not randomized in the factorial intervention)
Interventions
Behavioral 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.
A weekly goal planning tool that allows participants to adjust their dietary goals and make a specific plan for the week.
Receive 3 brief telephone or video coach sessions (20-30 minutes) every other week following randomization.
Switch 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.
Increased frequency of text messages (1-2 per day), highly personalized based on past and current dietary adherence and weight change.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Untreated thyroid disease or any changes (type or dose) in thyroid medication in the last 6 months
- Hospitalization for depression or other psychiatric disorders within the past 12 months
- History of psychotic disorder or bipolar disorder
- Currently participating in a weight loss, nutrition, or physical activity study or program or other study that would interfere with this study
- Currently using prescription medications with known effects on appetite or weight (e.g., oral steroids, weight loss medications), except individuals on a stable dose of SSRIs for 3 months
- Current use of bone acting medications (e.g., raloxifene, calcitonin, parathyroid hormone during the past year, PTH-analogues \[e.g., teriparatide, abaloparatide\], sclerostin inhibitors (romosozumbab), RANK ligand inhibitors (denosumab) or bisphosphonates during the last two years
- Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q; items 1-4)
- Report a health condition for which the program's dietary and physical activity recommendations would be unsafe, including hospitalization for heart failure, myocardial infarction or stroke in the past year, chronic kidney disease stage IV or V, liver failure or cirrhosis, chronic obstructive pulmonary disease on oxygen or requiring steroids, osteoporosis on medication, sarcopenia, history of fragility fractures, or dementia
- Other health problems that may influence the ability to walk for physical activity or be associated with unintentional weight change, including current cancer diagnosis, cancer treatment within the past 5 years or tuberculosis
- Previous surgical procedure for weight loss or planned weight loss surgery in the next year
- Another member of the household is a participant or staff member on this trial
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2026
First Posted
May 13, 2026
Study Start (Estimated)
March 1, 2027
Primary Completion (Estimated)
September 1, 2029
Study Completion (Estimated)
October 1, 2029
Last Updated
May 15, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Access Criteria
- The shared data will have a persistent unique identifier (DOI) from the UNC Dataverse repository. The data will also be discoverable online through a standard web search of the study-level metadata as well as the persistent pointer from the DOI to the dataset.
Deidentified individual data that supports the primary outcome results will be made available through the UNC Dataverse (https://dataverse.unc.edu/).