NCT06311175

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

April 30, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2024

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

7 months

First QC Date

January 3, 2024

Last Update Submit

March 18, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • Compliance with diet tracking prescription

    percent of prescribed days with complete tracking

    8 weeks

  • Persistence with diet tracking prescription

    percent of days of complete tracking in week 8

    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

    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.

    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.

    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.

    8 weeks

Secondary Outcomes (1)

  • Diet Tracking One Month Post-Intervention

    12 weeks

Study Arms (3)

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.

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.

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.

Behavioral: Dietary Tracking Prescription

Interventions

Dietary tracking prescriptions to follow during a digital weight loss intervention.

50% Tracking Prescription66% Tracking PrescriptionStandard Diet Tracking Prescription

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut

Storrs, Connecticut, 06269, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sherry Pagoto, PhD

    University of Connecticut

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of three intervention groups in parallel for the duration of the study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 3, 2024

First Posted

March 15, 2024

Study Start

April 30, 2024

Primary Completion

November 22, 2024

Study Completion

December 1, 2024

Last Updated

March 19, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations