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ObesityAGILENCT04922216

Adaptive Goals and Interventions for Lifestyle Enhancement

A study testing Core, Standard Diet Monitoring and Simplified Diet Monitoring in people with Obesity, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Mobile obesity interventions have the potential to reach a diverse population in need; however, while effective, have not resulted in weight losses obtained in in-person interventions. Read more about this study

Who is it for?
Ages 18 to 39 years
Conditions the study is for
Obesity
What is being tested?
Core, Standard Diet Monitoring and Simplified Diet Monitoring
Could I receive a placebo?
No, everyone receives an active treatment
How many people
759 participants
Where
1 siteUnited States
Study dates
28 Apr 2022to 1 Jul 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 39 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • body mass index (BMI) of 25-45 kg/m^2
  • English-speaking and writing
  • own a smartphone with a data and text messaging plan
  • willing to be randomized to any levels of the factors

Who cannot join

  • Type 1 diabetes or currently receiving medical treatment for Type 2 diabetes
  • Other health problems which may influence the ability to walk for physical activity or be associated with unintentional weight change, including cancer treatment within the past 5 years or tuberculosis
  • 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)
  • Lost 10 or more pounds (and kept it off) in the last 6 months
  • Currently taking weight loss medications
  • Report a past diagnosis of or current treatment for a DSM-V (Diagnostic and Statistical Manual 5) eating disorder (anorexia nervosa or bulimia nervosa)
Show all 11Show fewer
  • Currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 6 months
  • Hospitalization for depression or other psychiatric disorder within the past 12 months
  • History of psychotic disorder or bipolar disorder
  • Another member of the household is a participant or staff member on this trial
  • Currently participating in a weight loss, nutrition or physical activity study or program or other study that would interfere with this study

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514

Other trials in United States

About this study

Official title: Optimization of a mHealth Behavioral Weight Loss Intervention for Young Adults

Mobile obesity interventions have the potential to reach a diverse population in need; however, while effective, have not resulted in weight losses obtained in in-person interventions. Newer digital approaches called Just-in-Time Adaptive Interventions (JITAI) that offer adaptive, personalized feedback 'when needed' and in 'real time' offer an opportunity to use digital health tools "just in time". This study seeks to identify the optimal components of a comprehensive weight loss JITAI that results in weight losses that meet or exceed those in existing remotely delivered interventions.

Read the detailed description

Obesity has reached epidemic proportions in the United States and is recognized as a major cause of morbidity and mortality. Young adults (18-35 years) are at particularly high risk for weight gain and obesity. In-person behavioral interventions generally produce clinically significant weight losses; however, cost and access limit their potential to reduce obesity at a population level. Although web-based interventions that mimic the structure of weekly face-to-face treatment have proven a viable alternative treatment, weight losses are generally smaller than in-person treatment. Exclusively mobile treatments have been less effective, producing 1-3 kgs over 6 months. Newer digital intervention approaches called "Just-in-Time Adaptive Interventions" (JITAIs) promise to improve upon outcomes by offering adaptive, personalized feedback on behavior "when needed" in "real time," rather than on a fixed schedule. This "just-in-time," or JIT, approach is made possible by the emergence of low-cost and widely available digital health tools that allow for the collection of continually updated health data. However, few studies have used JIT approaches in remotely delivered, fully scalable weight loss interventions. Although JITAIs are a potentially transformative approach to delivering obesity interventions, a major obstacle in their development is efficient selection of components and systematic design of an optimized intervention package that produces clinically meaningful weight losses with a population-level strategy. To solve this problem, this trial will use the Multiphase Optimization Strategy (MOST), an engineering-inspired framework, and a highly efficient experimental design to identify which levels of 5 intervention components contribute meaningfully to change in weight over 6 months among young adults with overweight and obesity. All participants (n=608) will receive a core 6-month weight loss intervention that includes evidence-based lessons, behavioral skills training, and daily weighing. With the goal of determining if greater adaptation will lead to greater weight loss, participants will be randomized to standard versus more adaptive options of 5 additional intervention components: 1) diet monitoring approach (standard vs. simplified), 2) adaptive physical activity goals (weekly vs. daily), 3) decision points for message timing (fixed vs. adaptive), 4) decision rules for message content (standard vs. adaptive), and 5) message choice (no vs. yes). Candidate components have been carefully selected from empirical evidence, tested in prior studies conducted by the research team, or in a pilot micro-randomized trial conducted by the research team. Assessments will occur at 0, 3 and 6 months to accomplish the following specific aims: 1) Build an optimized JITAI consisting of the set of intervention components that yield the greatest improvement in weight change among young adults at 6 months; 2) Conduct mediation analyses to test the relationships between the intervention components and hypothesized proximal mediators (self-regulation, competence, relatedness, relevance, autonomy) and more distal behavioral mediators (dietary intake, physical activity, and daily self-weighting); and 3) Conduct exploratory analyses of program engagement.

Conditions
Obesity
Being tested
Core, Standard Diet Monitoring, Simplified Diet Monitoring, Adaptive Activity Goals (Daily), Adaptive Activity Goals (Weekly)
Keywords
behavioral intervention, JITAI (just-in-time adaptive intervention)
Medical subject headings
Obesity

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 behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.

  • Standard Diet MonitoringBehavioural

    Standard monitoring using smartphone tracking of all calorie intake.

  • Simplified Diet MonitoringBehavioural

    Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.

  • Adaptive Activity Goals (Daily)Behavioural

    Physical activity goals that adapt once each day using the participants' data derived from activity tracker.

  • Adaptive Activity Goals (Weekly)Behavioural

    Physical activity goals that adapt once each week using the participants' data derived from activity tracker.

  • Message Decision Points (Fixed)Behavioural

    Message timing is fixed and evaluated at specific times each day to determine message eligibility.

  • Message Decision Points (Adaptive)Behavioural

    Message timing is adaptive and derived from individual user data to determine message eligibility.

  • Message Decision Rules (Standard)Behavioural

    Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.

  • Message Decision Rules (Adaptive)Behavioural

    Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.

  • Message Choice (No)Behavioural

    Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision

  • Message Choice (Yes)Behavioural

    Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision.

Study groups in NCT04922216
Study groupRoleWhat they receive
Condition 1ExperimentalCore + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Standard Content + No Choice
Receives: Behavioral: Core; Behavioral: Standard Diet Monitoring; Behavioral: Adaptive Activity Goals (Daily); Behavioral: Message Decision Points (Fixed); Behavioral: Message Decision Rules (Standard); Behavioral: Message Choice (No)
Condition 2ExperimentalCore + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Standard Content + Choice
Receives: Behavioral: Core; Behavioral: Standard Diet Monitoring; Behavioral: Adaptive Activity Goals (Daily); Behavioral: Message Decision Points (Fixed); Behavioral: Message Decision Rules (Standard); Behavioral: Message Choice (Yes)
Condition 3ExperimentalCore + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Adaptive Content + No Choice
Receives: Behavioral: Core; Behavioral: Standard Diet Monitoring; Behavioral: Adaptive Activity Goals (Daily); Behavioral: Message Decision Points (Fixed); Behavioral: Message Decision Rules (Adaptive); Behavioral: Message Choice (No)
Condition 4ExperimentalCore + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Adaptive Content + Choice
Receives: Behavioral: Core; Behavioral: Standard Diet Monitoring; Behavioral: Adaptive Activity Goals (Daily); Behavioral: Message Decision Points (Fixed); Behavioral: Message Decision Rules (Adaptive); Behavioral: Message Choice (Yes)
Condition 5ExperimentalCore+Standard Diet Monitoring+Daily Activity Goal+Adaptive Timing+Standard Content+No Choice
Receives: Behavioral: Core; Behavioral: Standard Diet Monitoring; Behavioral: Adaptive Activity Goals (Daily); Behavioral: Message Decision Points (Adaptive); Behavioral: Message Decision Rules (Standard); Behavioral: Message Choice (No)
Condition 6ExperimentalCore + Standard Diet Monitoring + Daily Activity Goal + Adaptive Timing + Standard Content + Choice
Receives: Behavioral: Core; Behavioral: Standard Diet Monitoring; Behavioral: Adaptive Activity Goals (Daily); Behavioral: Message Decision Points (Adaptive); Behavioral: Message Decision Rules (Standard); Behavioral: Message Choice (Yes)
Condition 7ExperimentalCore+ Standard Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice
Receives: Behavioral: Core; Behavioral: Standard Diet Monitoring; Behavioral: Adaptive Activity Goals (Daily); Behavioral: Message Decision Points (Adaptive); Behavioral: Message Decision Rules (Adaptive); Behavioral: Message Choice (No)
Condition 8ExperimentalCore + Standard Diet Monitoring + Daily Activity Goal + Adaptive Timing + Adaptive Content + Choice
Receives: Behavioral: Core; Behavioral: Standard Diet Monitoring; Behavioral: Adaptive Activity Goals (Daily); Behavioral: Message Decision Points (Adaptive); Behavioral: Message Decision Rules (Adaptive); Behavioral: Message Choice (Yes)
Condition 9ExperimentalCore + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Standard Content + No Choice
Receives: Behavioral: Core; Behavioral: Standard Diet Monitoring; Behavioral: Adaptive Activity Goals (Weekly); Behavioral: Message Decision Points (Fixed); Behavioral: Message Decision Rules (Standard); Behavioral: Message Choice (No)
Condition 10ExperimentalCore + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Standard Content + Choice
Receives: Behavioral: Core; Behavioral: Standard Diet Monitoring; Behavioral: Adaptive Activity Goals (Weekly); Behavioral: Message Decision Points (Fixed); Behavioral: Message Decision Rules (Standard); Behavioral: Message Choice (Yes)
Condition 11ExperimentalCore + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Adaptive Content + No Choice
Receives: Behavioral: Core; Behavioral: Standard Diet Monitoring; Behavioral: Adaptive Activity Goals (Weekly); Behavioral: Message Decision Points (Fixed); Behavioral: Message Decision Rules (Adaptive); Behavioral: Message Choice (No)
Condition 12ExperimentalCore + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Adaptive Content + Choice
Receives: Behavioral: Core; Behavioral: Standard Diet Monitoring; Behavioral: Adaptive Activity Goals (Weekly); Behavioral: Message Decision Points (Fixed); Behavioral: Message Decision Rules (Adaptive); Behavioral: Message Choice (Yes)
Condition 13ExperimentalCore+Standard Diet Monitoring+Weekly Activity Goal+Adaptive Timing+Standard Content+No Choice
Receives: Behavioral: Core; Behavioral: Standard Diet Monitoring; Behavioral: Adaptive Activity Goals (Weekly); Behavioral: Message Decision Points (Adaptive); Behavioral: Message Decision Rules (Standard); Behavioral: Message Choice (No)
Condition 14ExperimentalCore + Standard Diet Monitoring + Weekly Activity Goal + Adaptive Timing + Standard Content + Choice
Receives: Behavioral: Core; Behavioral: Standard Diet Monitoring; Behavioral: Adaptive Activity Goals (Weekly); Behavioral: Message Decision Points (Adaptive); Behavioral: Message Decision Rules (Standard); Behavioral: Message Choice (Yes)
Condition 15ExperimentalCore + Standard Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice
Receives: Behavioral: Core; Behavioral: Standard Diet Monitoring; Behavioral: Adaptive Activity Goals (Weekly); Behavioral: Message Decision Points (Adaptive); Behavioral: Message Decision Rules (Adaptive); Behavioral: Message Choice (No)
Condition 16ExperimentalCore + Standard Diet Monitoring + Weekly Activity Goal + Adaptive Timing + Adaptive Content + Choice
Receives: Behavioral: Core; Behavioral: Standard Diet Monitoring; Behavioral: Adaptive Activity Goals (Weekly); Behavioral: Message Decision Points (Adaptive); Behavioral: Message Decision Rules (Adaptive); Behavioral: Message Choice (Yes)
Condition 17ExperimentalCore+ Simplified Diet Monitoring+ Daily Activity Goal+ Fixed Timing+ Standard Content+ No Choice
Receives: Behavioral: Core; Behavioral: Simplified Diet Monitoring; Behavioral: Adaptive Activity Goals (Daily); Behavioral: Message Decision Points (Fixed); Behavioral: Message Decision Rules (Standard); Behavioral: Message Choice (No)
Condition 18ExperimentalCore+ Simplified Diet Monitoring+ Daily Activity Goal+ Fixed Timing+ Standard Content+ Choice
Receives: Behavioral: Core; Behavioral: Simplified Diet Monitoring; Behavioral: Adaptive Activity Goals (Daily); Behavioral: Message Decision Points (Fixed); Behavioral: Message Decision Rules (Standard); Behavioral: Message Choice (Yes)
Condition 19ExperimentalCore+ Simplified Diet Monitoring+ Daily Activity Goal+ Fixed Timing+ Adaptive Content+ No Choice
Receives: Behavioral: Core; Behavioral: Simplified Diet Monitoring; Behavioral: Adaptive Activity Goals (Daily); Behavioral: Message Decision Points (Fixed); Behavioral: Message Decision Rules (Adaptive); Behavioral: Message Choice (No)
Condition 20ExperimentalCore + Simplified Diet Monitoring + Daily Activity Goal + Fixed Timing + Adaptive Content + Choice
Receives: Behavioral: Core; Behavioral: Simplified Diet Monitoring; Behavioral: Adaptive Activity Goals (Daily); Behavioral: Message Decision Points (Fixed); Behavioral: Message Decision Rules (Adaptive); Behavioral: Message Choice (Yes)
Condition 21ExperimentalCore+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Standard Content+ No Choice
Receives: Behavioral: Core; Behavioral: Simplified Diet Monitoring; Behavioral: Adaptive Activity Goals (Daily); Behavioral: Message Decision Points (Adaptive); Behavioral: Message Decision Rules (Standard); Behavioral: Message Choice (No)
Condition 22ExperimentalCore+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Standard Content+ Choice
Receives: Behavioral: Core; Behavioral: Simplified Diet Monitoring; Behavioral: Adaptive Activity Goals (Daily); Behavioral: Message Decision Points (Adaptive); Behavioral: Message Decision Rules (Standard); Behavioral: Message Choice (Yes)
Condition 23ExperimentalCore+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice
Receives: Behavioral: Core; Behavioral: Simplified Diet Monitoring; Behavioral: Adaptive Activity Goals (Daily); Behavioral: Message Decision Points (Adaptive); Behavioral: Message Decision Rules (Adaptive); Behavioral: Message Choice (No)
Condition 24ExperimentalCore+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Adaptive Content+ Choice
Receives: Behavioral: Core; Behavioral: Simplified Diet Monitoring; Behavioral: Adaptive Activity Goals (Daily); Behavioral: Message Decision Points (Adaptive); Behavioral: Message Decision Rules (Adaptive); Behavioral: Message Choice (Yes)
Condition 25ExperimentalCore+ Simplified Diet Monitoring+ Weekly Activity Goal+ Fixed Timing+ Standard Content+ No Choice
Receives: Behavioral: Core; Behavioral: Simplified Diet Monitoring; Behavioral: Adaptive Activity Goals (Weekly); Behavioral: Message Decision Points (Fixed); Behavioral: Message Decision Rules (Standard); Behavioral: Message Choice (No)
Condition 26ExperimentalCore + Simplified Diet Monitoring + Weekly Activity Goal + Fixed Timing + Standard Content + Choice
Receives: Behavioral: Core; Behavioral: Simplified Diet Monitoring; Behavioral: Adaptive Activity Goals (Weekly); Behavioral: Message Decision Points (Fixed); Behavioral: Message Decision Rules (Standard); Behavioral: Message Choice (Yes)
Condition 27ExperimentalCore+ Simplified Diet Monitoring+ Weekly Activity Goal+ Fixed Timing+ Adaptive Content+ No Choice
Receives: Behavioral: Core; Behavioral: Simplified Diet Monitoring; Behavioral: Adaptive Activity Goals (Weekly); Behavioral: Message Decision Points (Fixed); Behavioral: Message Decision Rules (Adaptive); Behavioral: Message Choice (No)
Condition 28ExperimentalCore + Simplified Diet Monitoring + Weekly Activity Goal + Fixed Timing + Adaptive Content + Choice
Receives: Behavioral: Core; Behavioral: Simplified Diet Monitoring; Behavioral: Adaptive Activity Goals (Weekly); Behavioral: Message Decision Points (Fixed); Behavioral: Message Decision Rules (Adaptive); Behavioral: Message Choice (Yes)
Condition 29ExperimentalCore+ Simplified Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Standard Content+ No Choice
Receives: Behavioral: Core; Behavioral: Simplified Diet Monitoring; Behavioral: Adaptive Activity Goals (Weekly); Behavioral: Message Decision Points (Adaptive); Behavioral: Message Decision Rules (Standard); Behavioral: Message Choice (No)
Condition 30ExperimentalCore+ Simplified Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Standard Content+ Choice
Receives: Behavioral: Core; Behavioral: Simplified Diet Monitoring; Behavioral: Adaptive Activity Goals (Weekly); Behavioral: Message Decision Points (Adaptive); Behavioral: Message Decision Rules (Standard); Behavioral: Message Choice (Yes)
Condition 31ExperimentalCore+ Simplified Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice
Receives: Behavioral: Core; Behavioral: Simplified Diet Monitoring; Behavioral: Adaptive Activity Goals (Weekly); Behavioral: Message Decision Points (Adaptive); Behavioral: Message Decision Rules (Adaptive); Behavioral: Message Choice (No)
Condition 32ExperimentalCore + Simplified Diet Monitoring + Weekly Activity Goal + Adaptive Timing + Adaptive Content+Choice
Receives: Behavioral: Core; Behavioral: Simplified Diet Monitoring; Behavioral: Adaptive Activity Goals (Weekly); Behavioral: Message Decision Points (Adaptive); Behavioral: Message Decision Rules (Adaptive); Behavioral: Message Choice (Yes)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight (kg)

    Estimated mean weight change in kg from baseline to 6 months for each of the two levels of each component (factor) obtained from intent-to-treat (ITT) linear mixed models of analysis of variance. More negative values of weight change indicate greater weight loss (6-month weight - baseline weight).

    Measured: Baseline, 6 months

Secondary outcomes (13)
  1. Weight (kg)

    Estimated mean weight change in kg from baseline to 3 months for each of the two levels of each component (factor) obtained from intent-to-treat (ITT) linear mixed models of analysis of variance. More negative values of weight change indicate greater weight loss (3-month weight - baseline weight).

    Measured: Baseline, 3 months

  2. Percent of Participants Reaching >/= 5% Weight Loss

    Percent change in body weight will be calculated (6 month weight - baseline weight/100) and determined to be at or above 5% indicating a clinically significant change.

    Measured: Baseline to 6 months

  3. Diet

    Change in daily caloric intake from baseline to 6 months as measured using the self-administered National Cancer Institute's Automated Self- Administered 24-hour Recall (ASA-24), a 24-hour recall that is self-administered on a week day and a weekend day at each timepoint. Change calculated as (daily kcal at 6 months - daily kcal at baseline).

    Measured: Baseline, 6 months

  4. Physical Activity

    Change in physical activity from baseline to 3 and 6 months as measured using the Paffenbarger Physical Activity Questionnaire (PPAQ). The PPAQ assesses amount of planned and lifestyle associated physical activity performed during a typical week. The PPAQ consists of three components: (1) stair climbing, (2) walking, and (3) sports and recreation. Participants report the frequency and duration of physical activity in the past week. Scoring yields energy expenditure from physical activity per week (kcal/week). Higher scores translate into greater energy expenditure per week (i.e.,better outcome). Range is 0 - no theoretical maximum. Outcome is change in kcal burned per week.

    Measured: Baseline,3 months, 6 months

  5. Sedentary Behavior Score

    Change in sedentary behavior from baseline to 3 and 6 months as measured using the 12- item Sedentary Behavior Questionnaire which asks respondents to indicate the number of hours they spend on a typical weekday and a typical weekend day doing each of six activities. The scale ranges from "none" to "6 or more hours" for each item. Higher values on the Sedentary Behavior Questionnaire indicate greater amount of time spent in sedentary behavior. Range is 0 to 24 hours and outcome is change in minutes per day.

    Measured: Baseline, 3 months, 6 months

  6. Autonomy Support Score

    Autonomy support at 3 and 6 months. Items are adapted from the Health Care Climate Questionnaire, which is a measure of how the participant perceives support from a healthcare provider, to measure autonomy support from the program. The scale includes 15 items rated on a scale of 1 (strongly disagree) to 7 (strongly agree) (e.g., "I feel that [the program] has provided me choices and options.") Scores are calculated by averaging the individual item scores (with item 13 reverse-scored). Higher average scores represent a higher level of perceived autonomy support. Outcomes are the mean value at 3 months and the mean value at 6 months.

    Measured: 3 months, 6 months

  7. Competence for Diet and Physical Activity Scores

    Change in perceived competence from baseline to 3 and 6 months as measured using the The Perceived Competence Scale. The Scale measures perceived competence for diet (4 items) and physical activity (4 items). Items are rated on a 7-point Likert scale (1 = not at all true, 7 = very true), and include items such as "I feel confident in my ability to maintain a healthy diet." Scores are summed for the items in the subscale (diet and physical activity) and the range for each subscale is 4 - 28. Greater values indicate higher levels of perceived competence for engaging in positive diet and physical activity behaviors. Scores are summed for the items in each subscale separately (diet and physical activity). Outcomes are change in perceived competence for diet and change in perceived competence for physical activity.

    Measured: Baseline, 3 months, 6 months

  8. Perceived Message Relevance Score

    Perceived message relevance at 3 and 6 months as measured using two items used in our previous work and adapted from previous studies of tailored messages. Participants were asked to rate how strongly they disagree or agree with the statements about messages being "written personally for me" and "applied to my life." Responses are on a 5-point scale from 1 (strongly disagree) to 5 (strongly agree). The values of the two items are averaged for a final score. Higher values indicate that a participant perceives the messages received in the program are more relevant to them.

    Measured: 3 months, 6 months

  9. Treatment Self-Regulation Score

    Change in treatment self-regulation from baseline to 3 and 6 months as measured using the Treatment Self-Regulation Questionnaire (TSRQ). The TSRQ assesses autonomous and controlled motivation for making changes in diet (15 items) and physical activity (15 items). Examples item: "Because I feel that I want to take responsibility for my own health" answered on a scale of 1 (not at all true) to 7 (very true)." Calculating the scores for the sub-scales will consist of averaging the items on that subscale. They are:

    Autonomous Regulation: 2, 3, 7, 10, 13, 16, 18, 19 Controlled Regulation: 1, 4, 5, 6, 8, 9, 11, 12, 14, 15, 17. Responses to the items within the subscale are averaged with the range of scores being 1 to 7. Higher values on each subscale indicate greater levels of that type of motivation. Outcomes are changes in autonomous and controlled motivation for diet at 3 and 6 months, and changes in autonomous and controlled motivation for activity at 3 and 6 months.

    Measured: Baseline, 3 months, 6 months

  10. Relatedness Score

    Relatedness at 3 and 6 months as measured with 3 items adapted from the 8-item Relatedness subscale of the Basic Need Satisfaction at Work Scale. Examples include "The messages demonstrate caring about me as a person" and are scored on a Likert scale from 1 (strongly disagree) to 7 (strongly agree). Responses are averaged with a range of 1 to 7. Higher scores indicate a higher level of perceived relatedness from the intervention messages.

    Measured: 3 months, 6 months

  11. Diet Self-monitoring Adherence

    Mean number of days of complete dietary tracking summed over the 6-month study period.

    Measured: Baseline to 6 months (daily)

  12. Weighing Adherence

    Mean number of days of self-weighing over the 6 month period.

    Measured: Baseline to 6 months (daily)

  13. Physical Activity Self-monitoring Adherence

    Mean number of days of physical activity tracking over the 6 month period as measured by Fitbit tracker wear.

    Measured: Baseline to 6 months (daily)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2021
  2. Study start28 Apr 2022
  3. Primary completion20 Jun 2024
  4. Study completion1 Jul 2024

Resources

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 five intervention components, each with two levels
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
759 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04922216
Sponsor's protocol ID
20-0765
Other IDs
R01DK125779
Acronym
AGILE
Status last verified
Oct 2023
First submitted
4 Jun 2021
Last updated
20 Jul 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nezami BT, Valle CG, Wasser HM, Hurley L, Hatley KE, Tate DF. Optimizing a mobile just-in-time adaptive intervention (JITAI) for weight loss in young adults: Rationale and design of the AGILE factorial randomized trial. Contemp Clin Trials. 2025 Mar;150:107808. doi: 10.1016/j.cct.2025.107808. Epub 2025 Jan 15.

    PubMed 39824380

Questions about this trial

What is this clinical trial studying?

A study testing Core, Standard Diet Monitoring and Simplified Diet Monitoring in people with Obesity, run by University of North Carolina, Chapel Hill 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 11 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: finished, as of the sponsor's last update on 20 Jul 2025. 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?

Yes. Results are posted in the registry (first posted 20 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight (kg) (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04922216, which also lists 1 linked publication.

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 20 Jul 2025.

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