Overweight and/or ObesityNCT07582536
Optimization of Dietary Adherence in a Mobile Weight Loss Intervention
A study testing Core, Switch to Simplified Diet Monitoring and Goal Autonomy/Planning in people with Overweight and/or Obesity, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight and/or Obesity
- What is being tested?
- Core, Switch to Simplified Diet Monitoring and Goal Autonomy/Planning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 580 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2027to Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
- Ability to provide consent (4 items adapted from the UBACC [University of California, San Diego Brief Assessment of Capacity to Consent])
- Reason to suspect that the participant would not adhere to the study intervention
- Does not live in the United States
- Cannot have participated in a research study conducted by UNC Weight Research Program in the past 2 years
- Individuals endorsing joint problems, current treatment for hypertension or hyperlipidemia, or osteoporosis diagnosis not on medication will be required to obtain written physician consent to participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
Karen E Hatley, MPH, 919-966-5852 ext. 2, keericks@email.unc.edu
Brooke T Nezami, PhD
About this study
Official title: Optimizing Dietary Adherence in a Mobile Behavioral Weight Loss Intervention for Adults
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.
Read the detailed description
SHIFT uses a highly efficient experimental design as part of the Multiphase Optimization Strategy (MOST) to optimize a 6-month behavioral weight loss intervention for improved dietary adherence among adults with overweight and obesity with initial nonresponse to the intervention. Investigators will test four unique treatment components added to a core mobile behavioral weight loss program.
All participants will receive the Core 6-month behavioral weight loss program, which is a comprehensive intervention that includes evidence-based behavior change strategies to promote self-monitoring and adherence to personalized dietary and activity goals. The program includes an individual kick-off session, native smartphone application, text messages, daily goals, self-monitoring of diet, weight, and physical activity, weekly lessons, tailored weekly feedback, and will start with 5-6 text messages per week. The intervention targets both dietary and physical activity changes, with a greater emphasis placed on improved dietary behaviors as the primary strategy for weight loss. Participants with lower than expected adherence to their dietary goals early in the program (weeks 3-8; "nonresponders") will be randomly assigned in a 2x2x2x2 factorial trial to the On or Off level of each of these 4 additional treatments added onto the core program: 1) switching dietary self-monitoring approach (Simplified Diet), 2) adding an autonomous goals and planning tool (Goal Autonomy + Planning), 3) adding just-in-time text messaging (JIT Messaging) 4) receiving 3 telehealth sessions with a health coach (Coach). Thus, each of these participants will receive 0-4 additional treatment components for the remainder of the 6-month program. Participants with recommended levels of dietary adherence in the first 8 weeks ("responders") remain in the Core program and are not randomized in the factorial trial.
All participants (those in the factorial trial and the responders who remain in the Core only) will complete assessments at baseline, 4 weeks (brief/online only), 8 weeks (brief/online only), 3 months, and 6 months. Primary and secondary research aims are limited to participants who are randomized into the factorial trial (estimated to be approximately 65% of the total sample). The primary aim is to determine the combination of additional intervention components that maximize dietary adherence from time of randomization to 6 months among participants with low early dietary adherence. A secondary outcome is percent of participants reaching 5% weight loss from baseline to 6 months.
Decision analysis for intervention value efficiency (DAIVE) will be the decision-making approach used to select the treatment components included in the final, optimized intervention. DAIVE uses a Bayesian factorial analysis of variance that maximizes the expected value of the outcome by evaluating the predicted value associated with all possible combinations of the components. DAIVE will be used maximize the expected value of both mean total weeks of dietary adherence from randomization to 6 months and proportion reaching 5% weight loss at 6 months.
- Conditions
- Overweight and/or Obesity
- Being tested
- Core, Switch to Simplified Diet Monitoring, Goal Autonomy/Planning, Just-in-time (JIT) Messaging, Coach Sessions
- Keywords
- behavioral intervention, weight loss, mHealth intervention, dietary recommendations
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoreBehavioural
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.
Switch to Simplified Diet MonitoringBehavioural
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.
Goal Autonomy/PlanningBehavioural
A weekly goal planning tool that allows participants to adjust their dietary goals and make a specific plan for the week.
Just-in-time (JIT) MessagingBehavioural
Increased frequency of text messages (1-2 per day), highly personalized based on past and current dietary adherence and weight change.
Coach SessionsBehavioural
Receive 3 brief telephone or video coach sessions (20-30 minutes) every other week following randomization.
| Study group | Role | What they receive |
|---|---|---|
| Condition 1 | Experimental | Core + Switch to Simplified Diet Monitoring + Goal Autonomy/Planning + Just-in-time (JIT) Messaging + Coach Sessions Receives: Behavioral: Core; Behavioral: Switch to Simplified Diet Monitoring; Behavioral: Goal Autonomy/Planning; Behavioral: Just-in-time (JIT) Messaging; Behavioral: Coach Sessions |
| Condition 2 | Experimental | Core + Switch to Simplified Diet Monitoring + Goal Autonomy/Planning + Just-in-time (JIT) Messaging Receives: Behavioral: Core; Behavioral: Switch to Simplified Diet Monitoring; Behavioral: Goal Autonomy/Planning; Behavioral: Just-in-time (JIT) Messaging |
| Condition 3 | Experimental | Core + Switch to Simplified Diet Monitoring + Goal Autonomy/Planning + Coach Sessions Receives: Behavioral: Core; Behavioral: Switch to Simplified Diet Monitoring; Behavioral: Goal Autonomy/Planning; Behavioral: Coach Sessions |
| Condition 4 | Experimental | Core + Switch to Simplified Diet Monitoring + Goal Autonomy/Planning Receives: Behavioral: Core; Behavioral: Switch to Simplified Diet Monitoring; Behavioral: Goal Autonomy/Planning |
| Condition 5 | Experimental | Core + Switch to Simplified Diet Monitoring + Just-in-time (JIT) Messaging + Coach Sessions Receives: Behavioral: Core; Behavioral: Switch to Simplified Diet Monitoring; Behavioral: Just-in-time (JIT) Messaging; Behavioral: Coach Sessions |
| Condition 6 | Experimental | Core + Switch to Simplified Diet Monitoring + Just-in-time (JIT) Messaging Receives: Behavioral: Core; Behavioral: Switch to Simplified Diet Monitoring; Behavioral: Just-in-time (JIT) Messaging |
| Condition 7 | Experimental | Core + Switch to Simplified Diet Monitoring + Coach Sessions Receives: Behavioral: Core; Behavioral: Switch to Simplified Diet Monitoring; Behavioral: Coach Sessions |
| Condition 8 | Experimental | Core + Switch to Simplified Diet Monitoring Receives: Behavioral: Core; Behavioral: Switch to Simplified Diet Monitoring |
| Condition 9 | Experimental | Core with Standard Diet Monitoring + Goal Autonomy/Planning + Just-in-time (JIT) Messaging + Coach Sessions Receives: Behavioral: Core; Behavioral: Goal Autonomy/Planning; Behavioral: Just-in-time (JIT) Messaging; Behavioral: Coach Sessions |
| Condition 10 | Experimental | Core with Standard Diet Monitoring + Goal Autonomy/Planning + Just-in-time (JIT) Messaging Receives: Behavioral: Core; Behavioral: Goal Autonomy/Planning; Behavioral: Just-in-time (JIT) Messaging |
| Condition 11 | Experimental | Core with Standard Diet Monitoring + Goal Autonomy/Planning + Coach Sessions Receives: Behavioral: Core; Behavioral: Goal Autonomy/Planning; Behavioral: Coach Sessions |
| Condition 12 | Experimental | Core with Standard Diet Monitoring + Goal Autonomy/Planning Receives: Behavioral: Core; Behavioral: Goal Autonomy/Planning |
| Condition 13 | Experimental | Core with Standard Diet Monitoring + Just-in-time (JIT) Messaging + Coach Sessions Receives: Behavioral: Core; Behavioral: Just-in-time (JIT) Messaging; Behavioral: Coach Sessions |
| Condition 14 | Experimental | Core with Standard Diet Monitoring + Just-in-time (JIT) Messaging Receives: Behavioral: Core; Behavioral: Just-in-time (JIT) Messaging |
| Condition 15 | Experimental | Core with Standard Diet Monitoring + Coach Sessions Receives: Behavioral: Core; Behavioral: Coach Sessions |
| Condition 16 | Experimental | Core with Standard Diet Monitoring Receives: Behavioral: Core |
| Core Only (Responders) | Other | Core program (participants who are not randomized in the factorial intervention) Receives: Behavioral: Core |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Time of randomization to 6 months
Secondary outcomes (4)
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.
Measured: Baseline to 6 months
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).
Measured: Time of randomization to 6 months
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.
Measured: Baseline, 6 months
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).
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study startMar 2027 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and/or ObesityStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This study uses a full factorial experimental design testing the efficacy of four intervention components, each with an on and off level.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 580 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07582536
- Sponsor's protocol ID
- 25-1211
- Other IDs
- R01HL178992
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the primary outcome results will be made available through the UNC Dataverse (https://dataverse.unc.edu/).
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Dietary Adherence in a Mobile Behavioral Weight Loss Intervention for Adults
- ClinicalTrials.gov ID
- NCT07582536
- Acronym / sponsor ID
- 25-1211
- Conditions
- Overweight and/or Obesity
- Keywords
- behavioral intervention, weight loss, mHealth intervention, dietary recommendations
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 580 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Mar 2027 (estimated)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
SHIFT uses a highly efficient experimental design as part of the Multiphase Optimization Strategy (MOST) to optimize a 6-month behavioral weight loss intervention for improved dietary adherence among adults with overweight and obesity with initial nonresponse to the intervention. Investigators will test four unique treatment components added to a core mobile behavioral weight loss program.
All participants will receive the Core 6-month behavioral weight loss program, which is a comprehensive intervention that includes evidence-based behavior change strategies to promote self-monitoring and adherence to personalized dietary and activity goals. The program includes an individual kick-off session, native smartphone application, text messages, daily goals, self-monitoring of diet, weight, and physical activity, weekly lessons, tailored weekly feedback, and will start with 5-6 text messages per week. The intervention targets both dietary and physical activity changes, with a greater emphasis placed on improved dietary behaviors as the primary strategy for weight loss. Participants with lower than expected adherence to their dietary goals early in the program (weeks 3-8; "nonresponders") will be randomly assigned in a 2x2x2x2 factorial trial to the On or Off level of each of these 4 additional treatments added onto the core program: 1) switching dietary self-monitoring approach (Simplified Diet), 2) adding an autonomous goals and planning tool (Goal Autonomy + Planning), 3) adding just-in-time text messaging (JIT Messaging) 4) receiving 3 telehealth sessions with a health coach (Coach). Thus, each of these participants will receive 0-4 additional treatment components for the remainder of the 6-month program. Participants with recommended levels of dietary adherence in the first 8 weeks ("responders") remain in the Core program and are not randomized in the factorial trial.
All participants (those in the factorial trial and the responders who remain in the Core only) will complete assessments at baseline, 4 weeks (brief/online only), 8 weeks (brief/online only), 3 months, and 6 months. Primary and secondary research aims are limited to participants who are randomized into the factorial trial (estimated to be approximately 65% of the total sample). The primary aim is to determine the combination of additional intervention components that maximize dietary adherence from time of randomization to 6 months among participants with low early dietary adherence. A secondary outcome is percent of participants reaching 5% weight loss from baseline to 6 months.
Decision analysis for intervention value efficiency (DAIVE) will be the decision-making approach used to select the treatment components included in the final, optimized intervention. DAIVE uses a Bayesian factorial analysis of variance that maximizes the expected value of the outcome by evaluating the predicted value associated with all possible combinations of the components. DAIVE will be used maximize the expected value of both mean total weeks of dietary adherence from randomization to 6 months and proportion reaching 5% weight loss at 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 17
- Model description
- This study uses a full factorial experimental design testing the efficacy of four intervention components, each with an on and off level.
| Arm | Type | Receives |
|---|---|---|
| Condition 1 | Experimental | Behavioral: Core, Behavioral: Switch to Simplified Diet Monitoring, Behavioral: Goal Autonomy/Planning, Behavioral: Just-in-time (JIT) Messaging, Behavioral: Coach SessionsCore + Switch to Simplified Diet Monitoring + Goal Autonomy/Planning + Just-in-time (JIT) Messaging + Coach Sessions |
| Condition 2 | Experimental | Behavioral: Core, Behavioral: Switch to Simplified Diet Monitoring, Behavioral: Goal Autonomy/Planning, Behavioral: Just-in-time (JIT) MessagingCore + Switch to Simplified Diet Monitoring + Goal Autonomy/Planning + Just-in-time (JIT) Messaging |
| Condition 3 | Experimental | Behavioral: Core, Behavioral: Switch to Simplified Diet Monitoring, Behavioral: Goal Autonomy/Planning, Behavioral: Coach SessionsCore + Switch to Simplified Diet Monitoring + Goal Autonomy/Planning + Coach Sessions |
| Condition 4 | Experimental | Behavioral: Core, Behavioral: Switch to Simplified Diet Monitoring, Behavioral: Goal Autonomy/PlanningCore + Switch to Simplified Diet Monitoring + Goal Autonomy/Planning |
| Condition 5 | Experimental | Behavioral: Core, Behavioral: Switch to Simplified Diet Monitoring, Behavioral: Just-in-time (JIT) Messaging, Behavioral: Coach SessionsCore + Switch to Simplified Diet Monitoring + Just-in-time (JIT) Messaging + Coach Sessions |
| Condition 6 | Experimental | Behavioral: Core, Behavioral: Switch to Simplified Diet Monitoring, Behavioral: Just-in-time (JIT) MessagingCore + Switch to Simplified Diet Monitoring + Just-in-time (JIT) Messaging |
| Condition 7 | Experimental | Behavioral: Core, Behavioral: Switch to Simplified Diet Monitoring, Behavioral: Coach SessionsCore + Switch to Simplified Diet Monitoring + Coach Sessions |
| Condition 8 | Experimental | Behavioral: Core, Behavioral: Switch to Simplified Diet MonitoringCore + Switch to Simplified Diet Monitoring |
| Condition 9 | Experimental | Behavioral: Core, Behavioral: Goal Autonomy/Planning, Behavioral: Just-in-time (JIT) Messaging, Behavioral: Coach SessionsCore with Standard Diet Monitoring + Goal Autonomy/Planning + Just-in-time (JIT) Messaging + Coach Sessions |
| Condition 10 | Experimental | Behavioral: Core, Behavioral: Goal Autonomy/Planning, Behavioral: Just-in-time (JIT) MessagingCore with Standard Diet Monitoring + Goal Autonomy/Planning + Just-in-time (JIT) Messaging |
| Condition 11 | Experimental | Behavioral: Core, Behavioral: Goal Autonomy/Planning, Behavioral: Coach SessionsCore with Standard Diet Monitoring + Goal Autonomy/Planning + Coach Sessions |
| Condition 12 | Experimental | Behavioral: Core, Behavioral: Goal Autonomy/PlanningCore with Standard Diet Monitoring + Goal Autonomy/Planning |
| Condition 13 | Experimental | Behavioral: Core, Behavioral: Just-in-time (JIT) Messaging, Behavioral: Coach SessionsCore with Standard Diet Monitoring + Just-in-time (JIT) Messaging + Coach Sessions |
| Condition 14 | Experimental | Behavioral: Core, Behavioral: Just-in-time (JIT) MessagingCore with Standard Diet Monitoring + Just-in-time (JIT) Messaging |
| Condition 15 | Experimental | Behavioral: Core, Behavioral: Coach SessionsCore with Standard Diet Monitoring + Coach Sessions |
| Condition 16 | Experimental | Behavioral: CoreCore with Standard Diet Monitoring |
| Core Only (Responders) | Other | Behavioral: CoreCore program (participants who are not randomized in the factorial intervention) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoreBehavioral 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. | Behavioural | Condition 1, Condition 10, Condition 11, Condition 12, Condition 13, Condition 14, Condition 15, Condition 16, Condition 2, Condition 3, Condition 4, Condition 5, Condition 6, Condition 7, Condition 8, Condition 9, Core Only (Responders) |
| Switch to Simplified Diet MonitoringSwitch 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. | Behavioural | Condition 1, Condition 2, Condition 3, Condition 4, Condition 5, Condition 6, Condition 7, Condition 8 |
| Goal Autonomy/PlanningA weekly goal planning tool that allows participants to adjust their dietary goals and make a specific plan for the week. | Behavioural | Condition 1, Condition 10, Condition 11, Condition 12, Condition 2, Condition 3, Condition 4, Condition 9 |
| Just-in-time (JIT) MessagingIncreased frequency of text messages (1-2 per day), highly personalized based on past and current dietary adherence and weight change. | Behavioural | Condition 1, Condition 10, Condition 13, Condition 14, Condition 2, Condition 5, Condition 6, Condition 9 |
| Coach SessionsReceive 3 brief telephone or video coach sessions (20-30 minutes) every other week following randomization. | Behavioural | Condition 1, Condition 11, Condition 13, Condition 15, Condition 3, Condition 5, Condition 7, Condition 9 |
Primary outcome
Total weeks of dietary goal adherence
Time frame: Time of randomization to 6 months
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).
4 secondary outcomes
Percent of participants reaching >= 5% weight loss
Time frame: Baseline to 6 months
Total days of dietary goal adherence
Time frame: Time of randomization to 6 months
Weight Change (kg)
Time frame: Baseline, 6 months
Dietary intake
Time frame: Baseline, 3 months, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the primary outcome results will be made available through the UNC Dataverse (https://dataverse.unc.edu/).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core, Switch to Simplified Diet Monitoring and Goal Autonomy/Planning in people with Overweight and/or Obesity, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karen E Hatley, MPH (919-966-5852 ext. 2, keericks@email.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total weeks of dietary goal adherence (time frame: Time of randomization to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.