ObesityNCT06311175
Diet Tracking Prescriptions for Weight Loss
A study testing Dietary Tracking Prescription in people with Obesity, run by University of Connecticut at 1 site in United States.
Trial summary
Lifestyle interventions are effective at producing modest weight loss. One of the strongest predictors of weight loss is food tracking, which involves logging all food and beverage consumed each day in an effort to stay within a daily calorie goal. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Dietary Tracking Prescription
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2024to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 27-45 kg/m2
- Wi-Fi connectivity at home
- Logs into Facebook at least 5 days per week over the past 2 weeks
- Has "liked", posted, or replied on Facebook at least twice a week over the past month
- Able to participate in the study in English
- Interested in losing weight
- Lives in US
Who cannot join
- Pregnant/lactating or plans to become pregnant during study period
- Reports having bipolar disorder, substance abuse, psychosis, an eating disorder, or severe depression
- Had bariatric surgery or plans to have surgery during the study
- Currently taking medication affecting weight
- Has lost ≥5% of weight in past 3 months
- Is participating or intends to participate in another weight loss program during the study
Show all 23Show fewer
- Chronic pain that interferes with the ability to exercise
- Type 1 Diabetes
- Type 2 Diabetes
- Unable to make dietary changes or increase physical activity
- Unable to walk ¼ mile unaided without stopping
- Currently smokes or vapes nicotine twice a week or more
- Has a digestive disorder/condition that precludes dietary changes
- Meets criteria for severe depression on the Patient Health Questionnaire-8 (score of >19)
- Does not currently own a smartphone
- Participated in previous weight loss studies under the PI
- Unable to attend the orientation webinar
- Had major surgery in past 6 months and have not been cleared by their doctor to resume physical activity and diet changes
- Plans to have major surgery in the next 6-months
- Has an implanted cardiac defibrillator or pacemaker
- Did not complete screening and on-board processes of study (screening survey, webinar, e-consent, baseline survey, app set-up, scale set-up, etc.)
- Prisoner; or
- Unable to provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut
Storrs, Connecticut, 06269
About this study
Official title: Mentoring in Mobile Health (mHealth) and Social Networking Interventions for Cardiovascular Disease Risk Reduction: Intervention Phase
Lifestyle interventions are effective at producing modest weight loss. One of the strongest predictors of weight loss is food tracking, which involves logging all food and beverage consumed each day in an effort to stay within a daily calorie goal. Standard lifestyle interventions prescribe daily food tracking for the length of the program which can range from 3-24 months. This can be a taxing prescription that is not feasible to do long term for many people. The purpose of this pilot feasibility randomized trial is to test the feasibility of 3 tracking prescriptions during an 8 week digital weight loss intervention: 1) tracking daily, 2) tracking two weeks on and one week off, 3) tracking every other week. Feasibility is defined as tracking prescription compliance, burden, acceptability, and perceived efficacy, and tracking self-efficacy. Diet tracking will be evaluated one month after the intervention ends so that groups can be compared on diet tracking maintenance.
Read the detailed description
The investigators propose a pilot randomized feasibility trial in which they will randomize 108 people to 3 remotely-delivered weight loss intervention groups that vary based on their diet tracking prescription. The primary outcome will be feasibility, acceptability, and perceived efficacy of the "lighter" tracking prescriptions. Each group will have 36 participants and the intervention will last 8 weeks. They will do assessments at baseline, 8 weeks, and 12 weeks. The 8 week assessment will include weight, diet tracking records, and a survey on acceptability. The 12 week assessment will evaluate weight and diet tracking in the month following the intervention which will allow them to explore diet tracking persistence in that time period. All three intervention groups will receive the same remotely delivered lifestyle intervention, but will vary based on three different tracking prescriptions: 1) Standard Diet Tracking Prescription: This group will be asked to track their diet every day for 8 weeks.
- 66% Tracking Prescription. This group will be asked to track for 2 weeks, then they will get a 1 week break, track for 2 more weeks and then get a 1 week break, and then track for 2 weeks. 3) 50% Tracking Prescription. This group will be asked to track every other week which would result in 4 weeks of tracking and 4 weeks off of tracking. The primary outcome of this trial is feasibility as defined as: 1) compliance with the tracking prescription (i.e., % of prescribed days with complete tracking, % tracking in week 8) 2) burden of tracking prescription (e.g., time consuming, hard to remember) 3) acceptability of tracking prescription (e.g., ease, plans to continue the prescription) 4) perceived efficacy of tracking prescription (e.g., "tracking this often is enough to help me lose weight"). 5) self-efficacy of diet tracking (e.g., "I feel confident I could continue this tracking prescription for the next 3 months"). 6) number of diet tracking days in the subsequent month. Percent weight loss at 8 and 12 weeks in each group will be exploratory outcomes and presented descriptively as this pilot is not powered to establish efficacy. Feasibility hypotheses and/or benchmarks are as follows:
- Tracking Adherence Hypothesis: Participants in groups 2 and 3 will have completed a significantly higher proportion of days of their total prescription than group 1. This will inform the future trial by demonstrating that adherence to the new prescriptions is higher than the standard prescription.
- Tracking Persistence Hypothesis: Participants in groups 2 and 3 will have tracked significantly more days in week 8 (last week of intervention) than participants in group 1. This will inform the future trial by demonstrating that a higher proportion of participants receiving the new prescriptions will still be tracking at week 8 than participants in the standard prescription. This is evidence that the abbreviated tracking prescriptions may result in a longer term tracking than the standard prescription.
- Tracking Burden Hypothesis: Participants in groups 2 and 3 will rate the burden of their tracking prescription significantly lower than participants in group 1. This will inform the future trial by demonstrating that the lighter tracking prescriptions will be viewed as less burdensome, which is further evidence that participants may be willing to track longer if they feel less burdened by the task.
- Tracking Acceptability Hypothesis: Participants in groups 2 and 3 will rate the acceptability of their tracking prescription significantly higher than participants in group 1. This will inform the future trial by demonstrating that the lighter tracking prescriptions will be viewed as more acceptable, which is further evidence that participants may be willing to track longer if they feel the task is easier.
- Perceived Efficacy Benchmark: At least 80% of participants in all groups will rate the perceived efficacy of their tracking prescription for weight loss to be high to very high. This will inform the future trial by demonstrating that the lighter tracking prescriptions are viewed by most as enough to result in weight loss. The investigators want to be careful that they do not lose faith in a lighter tracking prescription so they are testing two different light versions.
- Self-Efficacy for Tracking Hypothesis: Participants in groups 2 and 3 will have higher self-efficacy for their diet tracking prescription compared to group 1 and group 3 will have higher self-efficacy than group 2. This will inform the future trial by demonstrating that participants given the lighter tracking prescriptions will have higher self-efficacy for diet tracking which may be another indication that they may be willing to track over a longer period of time compared to the standard tracking prescription.
- Post-Intervention Tracking Adherence Benchmark: At least 80% of participants in groups 2 and 3 will match their diet tracking prescription in the subsequent month. This will inform the future trial by showing evidence for a high level of consistency for the lighter tracking prescriptions. If one of the two lighter prescriptions meets this benchmark, the investigators will select it for testing in the subsequent trial.
- Post-Intervention Tracking Prescription Hypothesis: A significantly higher proportion of participants in groups 2 and 3 will have tracked in the final week of the subsequent month compared to participants in group 1. This will inform the future trial by providing evidence that the lighter tracking prescriptions will lead to longer term tracking than the standard condition where tracking goes down precipitously over 2-3 months.
Findings from this pilot randomized feasibility trial will be used to inform an efficacy trial comparing one or both "light" tracking prescriptions to the standard tracking prescription on weight loss at 3, 6, and 12 months.
- Conditions
- Obesity
- Being tested
- Dietary Tracking Prescription
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Tracking PrescriptionBehavioural
Dietary tracking prescriptions to follow during a digital weight loss intervention.
| Study group | Role | What they receive |
|---|---|---|
| Standard Diet Tracking Prescription | Active comparator | This group will be asked to track their diet using a commercial mobile application every day for the 8 week digital weight loss intervention. Receives: Behavioral: Dietary Tracking Prescription |
| 66% Tracking Prescription | Experimental | This group will be asked to track their diet for 2 weeks, then they will get a 1 week break, track for 2 more weeks and then get a 1 week break, and then track for 2 weeks during the 8 week digital weight loss intervention. Receives: Behavioral: Dietary Tracking Prescription |
| 50% Tracking Prescription | Experimental | This group will be asked to track their diet every other week during the 8 week digital weight loss intervention. Receives: Behavioral: Dietary Tracking Prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance with diet tracking prescription
percent of prescribed days with complete tracking
Measured: 8 weeks
Persistence with diet tracking prescription
percent of days of complete tracking in week 8
Measured: 8 weeks
Burden of tracking prescription
Total score of three items: 5 point Likert scale ratings of how time consuming, hard to remember, and stressful the prescription was to follow. Minimum score =0, maximum score =12. Higher scores indicate higher burden
Measured: 8 weeks
Acceptability of tracking prescription
Total score of three items: 5 point Likert scale ratings of how easy the tracking prescription is, how much they like it, and their plans to continue the tracking prescription. Minimum score =0, maximum score =12. Higher scores indicate higher acceptability.
Measured: 8 weeks
Perceived efficacy of tracking prescription
Total score of how much they agree with 3 items on a 5 point Likert scale: tracking this often is enough to help me lose weight, tracking this often is enough to help me eat a healthier diet, and tracking this often is enough to keep me exercising. Minimum score =0, maximum score =12. Higher scores indicate higher perceived efficacy.
Measured: 8 weeks
Self-efficacy of diet tracking
Total score of how much they agree with 3 items on a 5 point Likert scale: "I feel confident I could continue this tracking prescription for the next month." "I feel confident I could continue this tracking prescription for 3 months." "I feel confident I can continue this tracking prescription for 6 months." Minimum score =0, maximum score =12. Higher scores indicate higher self-efficacy.
Measured: 8 weeks
Secondary outcomes (1)
Diet Tracking One Month Post-Intervention
Number of diet tracking days in the subsequent month
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start30 Apr 2024
- Primary completion22 Nov 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Parallel groups
- Model description
- Participants will be randomly assigned to one of three intervention groups in parallel for the duration of the study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherry Pagoto, University of Connecticut
- Investigators
- Sherry Pagoto, PhD, Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06311175
- Sponsor's protocol ID
- H20-0114
- Status last verified
- Mar 2025
- First submitted
- 3 Jan 2024
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mentoring in Mobile Health (mHealth) and Social Networking Interventions for Cardiovascular Disease Risk Reduction: Intervention Phase
- ClinicalTrials.gov ID
- NCT06311175
- Acronym / sponsor ID
- H20-0114
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 22 Nov 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 15 Mar 2024 (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.
Lifestyle interventions are effective at producing modest weight loss. One of the strongest predictors of weight loss is food tracking, which involves logging all food and beverage consumed each day in an effort to stay within a daily calorie goal. Standard lifestyle interventions prescribe daily food tracking for the length of the program which can range from 3-24 months. This can be a taxing prescription that is not feasible to do long term for many people. The purpose of this pilot feasibility randomized trial is to test the feasibility of 3 tracking prescriptions during an 8 week digital weight loss intervention: 1) tracking daily, 2) tracking two weeks on and one week off, 3) tracking every other week. Feasibility is defined as tracking prescription compliance, burden, acceptability, and perceived efficacy, and tracking self-efficacy. Diet tracking will be evaluated one month after the intervention ends so that groups can be compared on diet tracking maintenance.
Detailed description
The investigators propose a pilot randomized feasibility trial in which they will randomize 108 people to 3 remotely-delivered weight loss intervention groups that vary based on their diet tracking prescription. The primary outcome will be feasibility, acceptability, and perceived efficacy of the "lighter" tracking prescriptions. Each group will have 36 participants and the intervention will last 8 weeks. They will do assessments at baseline, 8 weeks, and 12 weeks. The 8 week assessment will include weight, diet tracking records, and a survey on acceptability. The 12 week assessment will evaluate weight and diet tracking in the month following the intervention which will allow them to explore diet tracking persistence in that time period. All three intervention groups will receive the same remotely delivered lifestyle intervention, but will vary based on three different tracking prescriptions: 1) Standard Diet Tracking Prescription: This group will be asked to track their diet every day for 8 weeks.
- 66% Tracking Prescription. This group will be asked to track for 2 weeks, then they will get a 1 week break, track for 2 more weeks and then get a 1 week break, and then track for 2 weeks. 3) 50% Tracking Prescription. This group will be asked to track every other week which would result in 4 weeks of tracking and 4 weeks off of tracking. The primary outcome of this trial is feasibility as defined as: 1) compliance with the tracking prescription (i.e., % of prescribed days with complete tracking, % tracking in week 8) 2) burden of tracking prescription (e.g., time consuming, hard to remember) 3) acceptability of tracking prescription (e.g., ease, plans to continue the prescription) 4) perceived efficacy of tracking prescription (e.g., "tracking this often is enough to help me lose weight"). 5) self-efficacy of diet tracking (e.g., "I feel confident I could continue this tracking prescription for the next 3 months"). 6) number of diet tracking days in the subsequent month. Percent weight loss at 8 and 12 weeks in each group will be exploratory outcomes and presented descriptively as this pilot is not powered to establish efficacy. Feasibility hypotheses and/or benchmarks are as follows:
- Tracking Adherence Hypothesis: Participants in groups 2 and 3 will have completed a significantly higher proportion of days of their total prescription than group 1. This will inform the future trial by demonstrating that adherence to the new prescriptions is higher than the standard prescription.
- Tracking Persistence Hypothesis: Participants in groups 2 and 3 will have tracked significantly more days in week 8 (last week of intervention) than participants in group 1. This will inform the future trial by demonstrating that a higher proportion of participants receiving the new prescriptions will still be tracking at week 8 than participants in the standard prescription. This is evidence that the abbreviated tracking prescriptions may result in a longer term tracking than the standard prescription.
- Tracking Burden Hypothesis: Participants in groups 2 and 3 will rate the burden of their tracking prescription significantly lower than participants in group 1. This will inform the future trial by demonstrating that the lighter tracking prescriptions will be viewed as less burdensome, which is further evidence that participants may be willing to track longer if they feel less burdened by the task.
- Tracking Acceptability Hypothesis: Participants in groups 2 and 3 will rate the acceptability of their tracking prescription significantly higher than participants in group 1. This will inform the future trial by demonstrating that the lighter tracking prescriptions will be viewed as more acceptable, which is further evidence that participants may be willing to track longer if they feel the task is easier.
- Perceived Efficacy Benchmark: At least 80% of participants in all groups will rate the perceived efficacy of their tracking prescription for weight loss to be high to very high. This will inform the future trial by demonstrating that the lighter tracking prescriptions are viewed by most as enough to result in weight loss. The investigators want to be careful that they do not lose faith in a lighter tracking prescription so they are testing two different light versions.
- Self-Efficacy for Tracking Hypothesis: Participants in groups 2 and 3 will have higher self-efficacy for their diet tracking prescription compared to group 1 and group 3 will have higher self-efficacy than group 2. This will inform the future trial by demonstrating that participants given the lighter tracking prescriptions will have higher self-efficacy for diet tracking which may be another indication that they may be willing to track over a longer period of time compared to the standard tracking prescription.
- Post-Intervention Tracking Adherence Benchmark: At least 80% of participants in groups 2 and 3 will match their diet tracking prescription in the subsequent month. This will inform the future trial by showing evidence for a high level of consistency for the lighter tracking prescriptions. If one of the two lighter prescriptions meets this benchmark, the investigators will select it for testing in the subsequent trial.
- Post-Intervention Tracking Prescription Hypothesis: A significantly higher proportion of participants in groups 2 and 3 will have tracked in the final week of the subsequent month compared to participants in group 1. This will inform the future trial by providing evidence that the lighter tracking prescriptions will lead to longer term tracking than the standard condition where tracking goes down precipitously over 2-3 months.
Findings from this pilot randomized feasibility trial will be used to inform an efficacy trial comparing one or both "light" tracking prescriptions to the standard tracking prescription on weight loss at 3, 6, and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of three intervention groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Standard Diet Tracking Prescription | Active comparator | Behavioral: Dietary Tracking PrescriptionThis group will be asked to track their diet using a commercial mobile application every day for the 8 week digital weight loss intervention. |
| 66% Tracking Prescription | Experimental | Behavioral: Dietary Tracking PrescriptionThis group will be asked to track their diet for 2 weeks, then they will get a 1 week break, track for 2 more weeks and then get a 1 week break, and then track for 2 weeks during the 8 week digital weight loss intervention. |
| 50% Tracking Prescription | Experimental | Behavioral: Dietary Tracking PrescriptionThis group will be asked to track their diet every other week during the 8 week digital weight loss intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- BMI 27-45 kg/m2
- Wi-Fi connectivity at home
- Logs into Facebook at least 5 days per week over the past 2 weeks
- Has "liked", posted, or replied on Facebook at least twice a week over the past month
- Able to participate in the study in English
Key exclusion criteria (23 listed)
- Pregnant/lactating or plans to become pregnant during study period
- Reports having bipolar disorder, substance abuse, psychosis, an eating disorder, or severe depression
- Had bariatric surgery or plans to have surgery during the study
- Currently taking medication affecting weight
- Has lost ≥5% of weight in past 3 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 |
|---|---|---|
| Dietary Tracking PrescriptionDietary tracking prescriptions to follow during a digital weight loss intervention. | Behavioural | 50% Tracking Prescription, 66% Tracking Prescription, Standard Diet Tracking Prescription |
Primary outcome
Compliance with diet tracking prescription
Time frame: 8 weeks
percent of prescribed days with complete tracking
Persistence with diet tracking prescription
Time frame: 8 weeks
percent of days of complete tracking in week 8
Burden of tracking prescription
Time frame: 8 weeks
Total score of three items: 5 point Likert scale ratings of how time consuming, hard to remember, and stressful the prescription was to follow. Minimum score =0, maximum score =12. Higher scores indicate higher burden
Acceptability of tracking prescription
Time frame: 8 weeks
Total score of three items: 5 point Likert scale ratings of how easy the tracking prescription is, how much they like it, and their plans to continue the tracking prescription. Minimum score =0, maximum score =12. Higher scores indicate higher acceptability.
Perceived efficacy of tracking prescription
Time frame: 8 weeks
Total score of how much they agree with 3 items on a 5 point Likert scale: tracking this often is enough to help me lose weight, tracking this often is enough to help me eat a healthier diet, and tracking this often is enough to keep me exercising. Minimum score =0, maximum score =12. Higher scores indicate higher perceived efficacy.
Self-efficacy of diet tracking
Time frame: 8 weeks
Total score of how much they agree with 3 items on a 5 point Likert scale: "I feel confident I could continue this tracking prescription for the next month." "I feel confident I could continue this tracking prescription for 3 months." "I feel confident I can continue this tracking prescription for 6 months." Minimum score =0, maximum score =12. Higher scores indicate higher self-efficacy.
1 secondary outcome
Diet Tracking One Month Post-Intervention
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Sherry Pagoto, PhD principal investigator
University of Connecticut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Tracking Prescription in people with Obesity, run by University of Connecticut 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 7 inclusion and 23 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 19 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Compliance with diet tracking prescription (time frame: 8 weeks). The study lists 6 primary outcomes in all. 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 19 Mar 2025.