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The goal of this clinical trial pilot is to determine the feasibility of an intervention to enhance weight management in patients who have stopped taking anti-obesity/weight management medications in primary care. The main questions it aims to answer are:
The new program will be compared to usual care.
The goal of this clinical trial pilot is to determine the feasibility of an intervention to enhance weight management in patients who have stopped taking anti-obesity/weight management medications in primary care. The main questions it aims to answer are:
The new program will be compared to usual care.
Participants will be asked to 1) complete short surveys about their medication use while taking the weight management medication, 2) complete online visits using study-provided scales, and 3) complete video visits with study staff monthly and online check-ins weekly, if assigned to the active treatment group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRISM Program | Experimental | This is a novel, remotely delivered, self-tailored intervention for post-anti-obesity medication discontinuation weight management. |
|
| Usual Care | No Intervention | Participants will continue to receive their regular, usual primary care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRISM Program | Behavioral | This is a novel, remotely delivered, self-tailored intervention for post-anti-obesity medication discontinuation weight management. The program incorporates standard-of-care behavioral intervention strategies for weight control to improve routine self-weighing, dietary self-monitoring, and increasing physical activity. The program includes an enhanced focus on strategies to reduce food cue reactivity. The program includes six monthly one-on-one sessions between study staff and participants, asynchronous online check-ins weekly for 12 weeks, and bi-weekly for 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | The recruitment rate will be defined as the number of participants randomized into the clinical trial per month. | Baseline |
| Acceptability of the Intervention | Self-reported Likert scale items will assess the overall satisfaction with the program, the likelihood participants would recommend the program to others, and their satisfaction with individual treatment components (e.g., the online check-ins). | 3 and 6 months post randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Medication adherence duration questions | A published measure will be used to assess adherence throughout the run-in period. These questions will be asked bi-weekly to assess adherence with minimal participant burden. | From consent to reported discontinuation, up to 22 months |
| Reasons for Discontinuation questions |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment efficiency | Recruitment efficiency will be defined as the days between the participant's last AOM dose and the date of randomization into the trial. | Baseline |
| Retention to the study | Retention to the study will be defined as an observed weight assessed during the 6-month assessment period. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melissa M Crane, PhD | Contact | 312-942-1282 | melissa_m_crane@rush.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Recruiting | Chicago | Illinois | 60130 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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This project is a randomized feasibility study with a run-in period
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A published measure will be used to assess reasons for discontinuation throughout the run-in period. These items will be asked only if participants indicate nonadherence. |
| Baseline |
| 6 months post-randomization |
| Intervention adherence | Intervention adherence will be defined as the number of one-on-one intervention sessions completed (out of 6 possible) and the number of online check-ins completed (out of 16). | Randomization to 6 months |
| Percent weight change | Weight data for outcome assessments (0, 3, and 6 months) will be collected remotely. | 3 and 6 months post-randomization |
| Adherence to dietary self-monitoring | Active treatment arm only: portion of days adherent to self-monitoring recommendations | Randomization to 6 months |
| Physical activity | Active treatment arm only: wearable tracking device will monitor their steps per day and minutes of medium and high-intensity activity as determined by the Fitbit algorithm. | Randomization to 6 months |
| Self-weighing frequency | A smart scale will be used to collect the frequency of self-weighing behavior. Participants will consent to the electronic scale being used to monitor their weighing behavior. Staff will monitor the days per week of recorded weights and the value of the weights to examine weighing and weight trends. | Randomization to 6 months |
| Intervention staff time | Staff will track the time spent conducting and scheduling intervention contacts, including time related to the one-on-one sessions and any additional support provided to participants. | Randomization to 6 months |
| Trial protocol staff time | Staff will track their time conducting recruitment efforts, consent visits, and conducting and scheduling assessment appointments. | Baseline to 6 months |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |