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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23HL127334 | U.S. NIH Grant/Contract | View source | |
| Pro00079803 | Other Identifier | Duke Unversity |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Duke University | OTHER |
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This pilot trial will test feasibility and acceptability of a primary care-based intervention that aims to increase the portion of patients who enter evidence-based behavioral weight loss treatment.
This trial is a pilot, pragmatic cluster randomized trial conducted in primary care clinics to determine intervention acceptability and the feasibility of proposed study protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | Participant receives intervention to motivate weight loss treatment initiation and access to weight loss treatment. |
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| Comparator Arm | Active Comparator | Participant receives access to weight loss treatment alone. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational Intervention | Behavioral | Participants complete web-based assessment and receive tailored feedback to motivate weight loss treatment initiation and informed that they have access to weight loss treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Attending 6 Month Follow-up Appointment | Count of enrolled participants who attend 6 month follow-up appointment | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention Acceptability (Acceptability Outcome) | Ratings on series of items developed by study team to assess patient perception of acceptability of the intervention. Items were created by study team. Possible range of 1 (strongly disagree) to 5 (strongly agree). Higher score reflects greater acceptability except for item 11. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Initiated Treatment Based on Program-provided Data and Self-report | Number of participants who initiate evidence-based weight loss treatment. Initiation is defined as completing at least one session (either group in-person session, one-on-one) | 6 months |
Primary care provider Inclusion criteria:
Patient inclusion criteria
Patient exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Megan A McVay, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31586443 | Derived | McVay MA, Yancy WS, Bennett GG, Levine E, Jung SH, Jung S, Anton S, Voils CI. A web-based intervention to increase weight loss treatment initiation: results of a cluster randomized feasibility and acceptability trial. Transl Behav Med. 2021 Feb 11;11(1):226-235. doi: 10.1093/tbm/ibz143. |
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None of the providers were withdrawn from the study. Of the 66 patients initially consented, 6 withdrew prior to learning their randomization assignment; 4 chose to withdraw for no stated reason; one was withdrawn by the study team due to being in treatment; and one was withdrawn by the study team due to canceling their index appointment.
All six providers who were recruited through a Duke Health primary care-based research network and were present at a primary care clinic provider meeting in February 2017, were eligible and consented to participate. Patients of the enrolled providers were recruited from May 2017 to August 2017 through an electronic health record database search.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mobilization Tool Arm | Participant receives intervention to motivate weight loss treatment initiation and access to weight loss treatment. Motivational Intervention: Participants complete web-based assessment and receive tailored feedback to motivate weight loss treatment initiation and informed that they have access to weight loss treatment. |
| FG001 | Comparator Tool Arm | Participant receives access to weight loss treatment alone. Comparator Intervention: Participants informed that they have access to weight loss treatment. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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One patient in the Comparator Arm completed the screener questionnaire but did not attend baseline session. Thus data is presented for 25 of the 26 enrolled patients for all variable except gender.
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| ID | Title | Description |
|---|---|---|
| BG000 | Mobilization Tool Arm | Participant receives intervention to motivate weight loss treatment initiation and access to weight loss treatment. Motivational Intervention: Participants complete web-based assessment and receive tailored feedback to motivate weight loss treatment initiation and informed that they have access to weight loss treatment. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | One patient in the Comparator Arm completed the screener questionnaire but did not attend baseline session. Thus data is presented for 25 of the 26 enrolled patients for all variable except gender. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Attending 6 Month Follow-up Appointment | Count of enrolled participants who attend 6 month follow-up appointment | Posted | Count of Participants | Participants | 6 months |
|
6 months (study period)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mobilization Tool Arm | Participant receives intervention to motivate weight loss treatment initiation and access to weight loss treatment. Motivational Intervention: Participants complete web-based assessment and receive tailored feedback to motivate weight loss treatment initiation and informed that they have access to weight loss treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Gastrointestinal disorders | Non-systematic Assessment | Participant was not hospitalized due to intervention. |
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A fully powered trial is needed to test intervention effectiveness.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Megan McVay | Department of Health Education and Behavior, College of Health and Human Performance, University of Florida | (352)294-7029 | megan.mcvay@ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 5, 2017 | Jan 2, 2019 | Prot_SAP_000.pdf |
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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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Staff recruiting participants and doing outcomes assessment will remain blinded to treatment assignment
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| Comparator Intervention | Other | Participants informed that they have access to weight loss treatment. |
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| BG001 |
| Comparator Tool Arm |
Participant receives access to weight loss treatment alone. Comparator Intervention: Participants informed that they have access to weight loss treatment. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | One patient in the Comparator Arm completed the screener questionnaire but did not attend baseline session. Thus data is presented for 25 of the 26 enrolled patients for all variable except gender. | Count of Participants | Participants |
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| Secondary | Intervention Acceptability (Acceptability Outcome) | Ratings on series of items developed by study team to assess patient perception of acceptability of the intervention. Items were created by study team. Possible range of 1 (strongly disagree) to 5 (strongly agree). Higher score reflects greater acceptability except for item 11. | Among mobilization tool participants, 28 patients progressed past the tool's introductory page, and 27 patients completed the tool. The post-tool acceptability survey was completed by 20 participants (72% of those who began the tool). | Posted | Mean | Standard Deviation | score on a item | 1 month |
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| Other Pre-specified | Number of Participants Who Initiated Treatment Based on Program-provided Data and Self-report | Number of participants who initiate evidence-based weight loss treatment. Initiation is defined as completing at least one session (either group in-person session, one-on-one) | Six participants withdrew prior to learning randomization condition and were not followed. | Posted | Count of Participants | Participants | 6 months |
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|
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| 0 |
| 34 |
| 1 |
| 34 |
| 0 |
| 34 |
| EG001 | Comparator Tool Arm | Participant receives access to weight loss treatment alone. Comparator Intervention: Participants informed that they have access to weight loss treatment. | 0 | 26 | 0 | 26 | 0 | 26 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
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| Item 4: Secure |
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| Item 5: Interested |
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| Item 6: Trustworthy |
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| Item 7: Enough time |
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| Item 8: Easy to understand |
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| Item 9: Easy to navigate |
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| Item 10: Useful |
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| Item 11: Too long |
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| Item 12: Enough information |
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| Treatment initiation, self-report |
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