Stepped Care for Weight Loss Maintenance

Last updated: May 6, 2025
Sponsor: Johns Hopkins University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Prevention

Weight Loss

Obesity

Treatment

Usual care

STEP

SELF

Clinical Study ID

NCT06151145
IRB00404188
R01NR020197
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 andphysical activity trackers

  • Home wireless access

Exclusion

Exclusion Criteria:

  • Serious medical condition or psychiatric condition that may pose a risk to theparticipant during intervention, cause a change in weight, or limit ability toadhere 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 causesignificant change in weight

  • History of bariatric surgery

  • Weight loss of >5% in the previous 6 months

  • Household member already participating in study

Study Design

Total Participants: 180
Treatment Group(s): 3
Primary Treatment: Usual care
Phase:
Study Start date:
February 01, 2024
Estimated Completion Date:
June 30, 2028

Connect with a study center

  • Johns Hopkins University

    Baltimore, Maryland 21205
    United States

    Active - Recruiting

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