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NCT06151145 | RECRUITING | Obesity

Stepped Care for Weight Loss Maintenance
Sponsor:

Johns Hopkins University

Brief Summary:

This study is a 3-group, parallel design, randomized controlled trial (RCT) in approximately 258 adults with obesity that will investigate whether a 16-week behavioral weight loss treatment and a 52-week stepped-care digital health intervention can improve the maintenance of a ≥ 5% weight loss. 16-week run-in (Phase 1). To qualify for randomization, participants must lose ≥ 5% of initial weight in the 16-week run-in. This loss will be achieved with the provision of weekly-group lifestyle counseling, which includes a partial meal replacement diet. 52-week randomized trial of 3 weight loss maintenance strategies (Phase 2): Participants who have achieved ≥ 5% weight loss during Phase 1 will be randomly assigned to 1 of 3 groups: 1. Participants in the Usual Care group will be emailed monthly educational modules with information on maintaining weight loss. 2. Participants in the SELF group will receive a wireless "smart" body weight scale and a wearable physical activity tracker, and daily text messages with tailored feedback to assist in weight loss maintenance. 3. Participants in the STEP group will be enrolled in an intervention that consists of 4 steps that are progressive and based on response to treatment. After 13 weeks at each step, participants who do not maintain a ≥5% weight loss or regain 2 percentage points of weight from the participants randomization value will move to a higher intensity step. Participants who maintain weight loss will stay at the same step.

Condition or disease

Obesity

Intervention/treatment

Usual care

SELF

STEP

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 180 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Stepped Care for Weight Loss Maintenance
Actual Study Start Date : 2024-02-01
Estimated Primary Completion Date : 2028-06
Estimated Study Completion Date : 2028-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • * BMI\>/=30 kg/m2 or \>/=27 kg/m2 with an obesity-related complication
  • * Age 18-70 years
  • * Completion of baseline assessment tasks
  • * Ability to engage in physical activity
  • * Own a smartphone capable of receiving text-messages and syncing to weight scales and physical activity trackers
  • * Home wireless access
Exclusion Criteria
  • * Serious medical condition or psychiatric condition that may pose a risk to the participant during intervention, cause a change in weight, or limit ability to adhere to the behavioral recommendations of the program
  • * Pregnant or planning pregnancy in the next 1.5 years
  • * Weight\>440 lbs
  • * Planned move out of the area in the next 1.5 years
  • * Recently began a course of or changed the dosage of medication that can cause significant change in weight
  • * History of bariatric surgery
  • * Weight loss of \>5% in the previous 6 months
  • * Household member already participating in study
Stepped Care for Weight Loss Maintenance

Location Details

NCT06151145

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How to Participate

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Locations

RECRUITING

United States, Maryland

Johns Hopkins University

Baltimore, Maryland, United States, 21205