Stepped Care for Weight Loss Maintenance

Obesity Clinical Trial

Official title:

Stepped Care for Weight Loss Maintenance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06151145
• Other study ID #: IRB00404188
• Secondary ID: R01NR020197
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: June 2028

Study information

• Verified date: February 2024
• Source: Johns Hopkins University
• Contact: Ariana M Chao, PhD, CRNP
• Phone: 4432876223
• Email: ariana.chao[@]jhu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: June 2028
• Est. primary completion date: June 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Behavioral:
• Usual care
Participants in usual care will be emailed monthly educational modules with information on maintaining weight loss.
• SELF
The SELF group will receive a wireless "smart" body weight scale and wearable physical activity tracker, and text messages.
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost effectiveness	To evaluate the incremental cost effectiveness per unit decrease in weight (kg) from a healthcare payer perspective	Up to 52 weeks
Primary	Weight (kg) change for STEP versus usual care	Weight change (kg) for STEP versus usual care	Baseline, 52 weeks
Primary	Weight (kg) change for SELF versus usual care	Weight change (kg) for SELF versus usual care	Baseline, 52 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Weight (kg) change for STEP versus SELF	Weight change (kg) for STEP versus SELF	Baseline, 52 weeks
Secondary	Change in days of self-weighing for STEP versus SELF	Self-weighing frequency for STEP versus SELF	Baseline, 52 weeks
Secondary	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
Secondary	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