Clinical trial NCT06151145: Stepped Care for Weight Loss Maintenance
Official title: Stepped Care for Weight Loss Maintenance
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Keywords: obesity
weight loss
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2023-11-30
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Weight (kg) change for STEP versus usual care
timeFrame: Baseline, 52 weeks
measure: Weight (kg) change for SELF versus usual care
timeFrame: Baseline, 52 weeks
Secondary outcomes:
measure: Change in self-weighing frequency (days) for STEP and SELF versus usual care
timeFrame: Baseline, 52 weeks
measure: Change in daily calorie intake for STEP and SELF vs usual care
timeFrame: Baseline, 52 weeks
measure: Change in physical activity (minutes) for STEP and SELF versus usual care
timeFrame: Baseline, 52 weeks
measure: Weight (kg) change for STEP versus SELF
timeFrame: Baseline, 52 weeks
measure: Change in days of self-weighing for STEP versus SELF
timeFrame: Baseline, 52 weeks
measure: Change in daily calorie intake for STEP versus SELF
timeFrame: Baseline, 52 weeks
measure: Change in self-reported minutes of Physical activity for STEP versus SELF
timeFrame: Baseline, 52 weeks
Other outcomes:
measure: Cost effectiveness
timeFrame: Up to 52 weeks
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Ariana M Chao, PhD, CRNP
role: PRINCIPAL_INVESTIGATOR
References: