Testing a Tailored Approach to Long-Term Weight Loss Success

NCT07577765 | Recruiting

• 2 other identifiers: IRB_001883101K01DK134800-01A1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to develop and test an adaptive, individually tailored intervention to prevent weight regain in people who have intentionally lost weight. The main questions it aims to answer are:

• Is an adaptive intervention with tailored re-engagement support feasible for individuals following intentional weight loss?
• Does this intervention prevent weight regain after intentional weight loss? Participants will:
• Complete a baseline assessment of body measurements
• Complete surveys on dietary intake, mental health, and physical activity Participants will also engage in a 26-week program, which involves:
• Receive regular educational texts/emails
• Fill out weekly online survey check-ins
• Weigh themselves at least weekly on a scale provided by the study
• Some participants may receive health coaching during portions of the study.
• Assessments will be repeated for all participants at the end of the intervention period.

Conditions

Weight Loss; Weight Regain; Obesity & Overweight

Outcome Measures

Primary Outcomes (10)

• Feasibility - Participant Retention

  Number of participants who continue to participate for all 26 weeks of the study and complete all study activities

  From enrollment to the end of the 26-week monitoring period

• Feasibility - Participant Adherence

  Number of participants who complete all study activities, including weekly weigh-ins, weekly surveys, and pre/post study visits.

  From enrollment to the end of the 26-week monitoring period

• Efficacy - Participant Weight

  From enrollment to the end of the 26-week monitoring period

• Efficacy - Participant Dietary Intake

  Dietary and nutritional data collected via self-report using the ASA24 (Automated Self-Administered 24-Hour Dietary Assessment Tool). This includes calories, protein, fats, and other nutrition information based on participant self-report of meals.

  From enrollment to the end of the 26-week monitoring period

• Efficacy - Eating Self-Efficacy in High-Risk Situations

  Eating self-efficacy in high-risk situations will be measured pre- \& post-intervention using the Weight Efficacy Lifestyle Questionnaire.

  From enrollment to the end of the 26-week monitoring period

• Efficacy - Eating Behavior Patterns

  Eating behavior patterns will be measured pre- \& post-intervention using the Three-Factor Eating Questionnaire.

  From enrollment to the end of the 26-week monitoring period

• Efficacy - Sleep/Rest Duration

  Sleep/rest duration will be measured in hours/day using the activPAL accelerometer, a thigh-worn device that objectively measures posture and movement. Participants will wear the device continuously for 7 consecutive days.

  From enrollment to the end of the 26-week monitoring period

• Efficacy - Daily Step Count

  Daily step count will be measured using the activPAL accelerometer, a thigh-worn device that objectively measures posture and movement. Participants will wear the device continuously for 7 consecutive days.

  From enrollment to the end of the 26-week monitoring period

• Efficacy - Sedentary Behavior (Sitting/Lying Time)

  Sedentary behavior will be measured in hours/day using the activPAL accelerometer, a thigh-worn device that objectively measures posture and movement. Participants will wear the device continuously for 7 consecutive days.

  From enrollment to the end of the 26-week monitoring period

• Efficacy - Standing Time

  Standing time will be measured in hours/day using the activPAL accelerometer, a thigh-worn device that objectively measures posture and movement. Participants will wear the device continuously for 7 consecutive days.

  From enrollment to the end of the 26-week monitoring period

Study Arms (1)

Adaptive Intervention

EXPERIMENTAL

Behavioral: Adaptive weight regain prevention

Interventions

Adaptive weight regain prevention BEHAVIORAL

Adaptive intervention that will tailor participant re-engagement with professional support (e.g. health coaches) based on behavioral triggers and anthropometric monitoring (diet changes, weight increase, failure to weigh weekly).

Adaptive Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI of ≥ 27 prior to weight loss
• Lost ≥ 7% of body mass in the past 6 months
• Weight loss was intentional
• No plans for weight loss surgery in the next 6 months
• Access to a smart device that can download applications and receive text messages
• Able to receive clearance for study participation from primary care provider

You may not qualify if:

• Pregnant or within 12 months postpartum, or planning pregnancy
• Uncontrolled conditions that affect overall health (cardiovascular, metabolic, renal, pulmonary, psychiatric, thyroid, cancers)
• Food insecure
• Bariatric surgery or cancer treatment within the past 5 years
• Active or recent (\<12 months) treatment/diagnosis of an eating disorder

Sponsors & Collaborators

• University of Utah: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

MeSH Terms

Conditions

Weight Loss; Obesity; Overweight

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Central Study Contacts

Josh Oliver

CONTACT

971-645-6693; joshua.oliver@hsc.utah.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: May 11, 2026
• Study Start: January 7, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)