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Recruiting NCT07577765

Testing a Tailored Approach to Long-Term Weight Loss Success

No phase Interventional Weight Loss Weight Regain Obesity & Overweight

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Adaptive weight regain prevention.
Who it may be relevant to
Registry conditions: Weight Loss, Weight Regain, Obesity & Overweight. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Pilot Testing an Adaptive Intervention for Weight Loss Maintenance

Overview

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.

Interventions

  • Behavioral Adaptive weight regain prevention
    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).

Primary outcome measures

  • Feasibility - Participant Retention [Time frame: From enrollment to the end of the 26-week monitoring period]
  • Feasibility - Participant Adherence [Time frame: From enrollment to the end of the 26-week monitoring period]
  • Efficacy - Participant Weight [Time frame: From enrollment to the end of the 26-week monitoring period]
  • Efficacy - Participant Dietary Intake [Time frame: From enrollment to the end of the 26-week monitoring period]
  • Efficacy - Eating Self-Efficacy in High-Risk Situations [Time frame: From enrollment to the end of the 26-week monitoring period]
  • Efficacy - Eating Behavior Patterns [Time frame: From enrollment to the end of the 26-week monitoring period]
  • Efficacy - Sleep/Rest Duration [Time frame: From enrollment to the end of the 26-week monitoring period]
  • Efficacy - Daily Step Count [Time frame: From enrollment to the end of the 26-week monitoring period]
  • Efficacy - Sedentary Behavior (Sitting/Lying Time) [Time frame: From enrollment to the end of the 26-week monitoring period]
  • Efficacy - Standing Time [Time frame: From enrollment to the end of the 26-week monitoring period]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • University of Utah — Salt Lake City

Identifiers

NCT: NCT07577765 · IRB_00188310 · 1K01DK134800-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗