Clinical trial

Stepped Care for Weight Loss Maintenance

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT06151145

Active, not recruitingNot applicableInterventional

What this study is 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 70 Years

SexAll

Healthy volunteersAccepted

ConditionObesity

Full registry 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

Treatments and study arms

Usual care

Behavioral

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

SELF

Behavioral

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

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.

Primary outcomes

Weight (kg) change for STEP versus usual careBaseline, 52 weeks

Weight change (kg) for STEP versus usual care

Weight (kg) change for SELF versus usual careBaseline, 52 weeks

Weight change (kg) for SELF versus usual care

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Johns Hopkins University🇺🇸 Baltimore, Maryland, United States

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