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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR020197 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | Active Comparator | Usual care |
|
| Text-message intervention with digital tools (SELF) | Experimental | Text-message intervention |
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| Stepped Care (STEP) | Experimental | Stepped care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual care | Behavioral | Participants in usual care will be emailed monthly educational modules with information on maintaining weight loss. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight (kg) change for STEP versus usual care | Weight change (kg) for STEP versus usual care | Baseline, 52 weeks |
| Weight (kg) change for SELF versus usual care | Weight change (kg) for SELF versus usual care | Baseline, 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in daily calorie intake for STEP and SELF vs usual care |
| Measure | Description | Time Frame |
|---|---|---|
| Cost effectiveness | To evaluate the incremental cost effectiveness per unit decrease in weight (kg) from a healthcare payer perspective | Up to 52 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ariana M Chao, PhD, CRNP | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21205 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| SELF | Behavioral | The SELF group will receive a wireless "smart" body weight scale and wearable physical activity tracker, and text messages. |
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| 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. |
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Change in daily calorie intake measured using 24-hour dietary recalls for STEP and SELF versus usual care
| Baseline, 52 weeks |
| 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 |
| Weight (kg) change for STEP versus SELF | Weight change (kg) for STEP versus SELF | Baseline, 52 weeks |
| Change in days of self-weighing for STEP versus SELF | Self-weighing frequency for STEP versus SELF | Baseline, 52 weeks |
| 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 |
| 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 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |