Stepped Care for Weight Loss Maintenance

Johns Hopkins University

Status: Enrolling

Conditions: Obesity

Treatments: Behavioral: SELF; Behavioral: Usual care; Behavioral: STEP

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06151145

IRB00404188

R01NR020197 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 3 patient groups

Usual care

Active Comparator group

Description:

Usual care

Treatment:

Behavioral: Usual care

Text-message intervention with digital tools (SELF)

Experimental group

Description:

Text-message intervention

Treatment:

Behavioral: SELF

Stepped Care (STEP)

Experimental group

Description:

Stepped care

Treatment:

Behavioral: STEP