Stepped Care for Weight Loss Maintenance

NCT06151145 | Recruiting DMC

• 2 other identifiers: IRB00404188R01NR020197
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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. 1.Participants in the Usual Care group will be emailed monthly educational modules with information on maintaining weight loss.
2. 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. 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.

Conditions

Obesity

Keywords

obesity; weight loss

Outcome Measures

Primary Outcomes (2)

• Weight (kg) change for STEP versus usual care

  Weight change (kg) for STEP versus usual care

  Baseline, 52 weeks

• Weight (kg) change for SELF versus usual care

  Weight change (kg) for SELF versus usual care

  Baseline, 52 weeks

Secondary Outcomes (7)

• Change in self-weighing frequency (days) for STEP and SELF versus usual care

  Baseline, 52 weeks

• Change in daily calorie intake for STEP and SELF vs usual care

  Baseline, 52 weeks

• Change in physical activity (minutes) for STEP and SELF versus usual care

  Baseline, 52 weeks

• Weight (kg) change for STEP versus SELF

  Baseline, 52 weeks

• Change in days of self-weighing for STEP versus SELF

  Baseline, 52 weeks

Other Outcomes (1)

• Cost effectiveness

  Up to 52 weeks

Study Arms (3)

Usual care

ACTIVE COMPARATOR

Usual care

Behavioral: Usual care

Text-message intervention with digital tools (SELF)

EXPERIMENTAL

Text-message intervention

Behavioral: SELF

Stepped Care (STEP)

EXPERIMENTAL

Stepped care

Behavioral: STEP

Interventions

Usual care BEHAVIORAL

Participants in usual care will be emailed monthly educational modules with information on maintaining weight loss.

Usual care

SELF BEHAVIORAL

The SELF group will receive a wireless "smart" body weight scale and wearable physical activity tracker, and text messages.

Text-message intervention with digital tools (SELF)

STEP BEHAVIORAL

The STEP intervention consists of 4 steps that are progressive and based on response to treatment. Step 1: Digital health intervention. The first step will be the digital health intervention as described under SELF. Step 2: Monthly, in-person counseling. Participants who move to Step 2 will be provided with monthly, in-person counseling. Step 3: Twice per month counseling. Step 3 will be twice-monthly counseling, spaced at every other week. Step 4: Meal replacements. Participants will be prescribed a partial meal replacement program.

Stepped Care (STEP)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

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

Study Officials

• Ariana M Chao, PhD, CRNP

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ariana M Chao, PhD, CRNP

CONTACT

4432876223; ariana.chao@jhu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: November 30, 2023
• Study Start: February 1, 2024
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 8, 2025

Record last verified: 2025-05

Locations

US (1)