Stepped Care for Weight Loss Maintenance

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Usual care; Behavioral: SELF; Behavioral: STEP

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual care	Behavioral: Usual care; Participants in usual care will be emailed monthly educational modules with information on maintaining weight loss.
Experimental: Text-message intervention with digital tools (SELF); Text-message intervention	Behavioral: SELF; The SELF group will receive a wireless "smart" body weight scale and wearable physical activity tracker, and text messages.
Experimental: Stepped Care (STEP); Stepped care	Behavioral: STEP; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in self-weighing frequency (days) for STEP and SELF versus usual care	Change in number of days of self-weighing for STEP and SELF versus usual care	Baseline, 52 weeks
Change in daily calorie intake for STEP and SELF vs usual care	Change in daily calorie intake measured using 24-hour dietary recalls for STEP and SELF versus usual care	Baseline, 52 weeks
Change in physical activity (minutes) for STEP and SELF versus usual care	Change in self-reported minutes of physical activity for STEP and SELF versus usual care	Baseline, 52 weeks
Weight (kg) change for STEP versus SELF	Weight change (kg) for STEP versus SELF	Baseline, 52 weeks
Change in days of self-weighing for STEP versus SELF	Self-weighing frequency for STEP versus SELF	Baseline, 52 weeks
Change in daily calorie intake for STEP versus SELF	Change in daily calorie intake measured using 24-hour dietary recalls for STEP versus SELF	Baseline, 52 weeks
Change in self-reported minutes of Physical activity for STEP versus SELF	Change in self-reported minutes of physical activity for STEP versus SELF	Baseline, 52 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost effectiveness	To evaluate the incremental cost effectiveness per unit decrease in weight (kg) from a healthcare payer perspective	Up to 52 weeks

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Ariana M Chao, PhD, CRNP, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: November 21, 2023
• First Submitted That Met QC Criteria: November 21, 2023
• First Posted (Actual): November 30, 2023

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: obesity; weight loss
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Body Weight Changes; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Weight Loss
• Other Study ID Numbers: IRB00404188; R01NR020197 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No