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NCT Number: NCT06151145

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. Weight (kg) change for STEP versus usual care

    Time frame: Baseline, 52 weeks

    Weight change (kg) for STEP versus usual care

  2. Weight (kg) change for SELF versus usual care

    Time frame: Baseline, 52 weeks

    Weight change (kg) for SELF versus usual care

Secondary outcomes

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

    Time frame: Baseline, 52 weeks

    Change in number of days of self-weighing for STEP and SELF versus usual care

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

    Time frame: Baseline, 52 weeks

    Change in daily calorie intake measured using 24-hour dietary recalls for STEP and SELF versus usual care

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

    Time frame: Baseline, 52 weeks

    Change in self-reported minutes of physical activity for STEP and SELF versus usual care

  4. Weight (kg) change for STEP versus SELF

    Time frame: Baseline, 52 weeks

    Weight change (kg) for STEP versus SELF

  5. Change in days of self-weighing for STEP versus SELF

    Time frame: Baseline, 52 weeks

    Self-weighing frequency for STEP versus SELF

  6. Change in daily calorie intake for STEP versus SELF

    Time frame: Baseline, 52 weeks

    Change in daily calorie intake measured using 24-hour dietary recalls for STEP versus SELF

  7. Change in self-reported minutes of Physical activity for STEP versus SELF

    Time frame: Baseline, 52 weeks

    Change in self-reported minutes of physical activity for STEP versus SELF

Other outcomes

  1. Cost effectiveness

    Time frame: Up to 52 weeks

    To evaluate the incremental cost effectiveness per unit decrease in weight (kg) from a healthcare payer perspective

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Nov 30, 2023
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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