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Although bariatric surgery is highly effective for inducing significant weight loss and resolution of comorbidities, weight regain following surgery is a common problem. This pilot study will test the feasibility and acceptability of an intervention designed to help bariatric surgery patients maintain weight loss. Findings from this pilot will provide the foundation for a randomized controlled trial to evaluate the efficacy of the intervention.
The first intervention telephone call will occur one week following the baseline assessment. Calls will be made weekly in the first month (weeks 1, 2, 3, 4) and biweekly calls during months 2-4 (weeks 6, 8, 10, 12, 14). The goal of this intervention is to increase adherence to recommendations that patients are already receiving from their bariatric team as part of standard of care. Thus, each call will address maintenance skill building and anticipatory problem solving based on the processes outlined in the investigators' conceptual model and operationalized in the investigators' previous weight loss maintenance protocol. Relapse prevention planning will help patients identify situations in which overeating is common in the bariatric population (e.g., loss of control eating related to emotions, disinhibition).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| maintenance | Experimental | behavioral intervention to increase adherence to lifestyle recommendations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| maintenance intervention | Behavioral | Participants will receive calls at weeks 1, 2, 3, 4, 6, 8, 10, 12, and 14 that focus on satisfaction with outcomes of behavior change, self-monitoring, relapse planning, and social support. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Rate | Percentage of contacted patients who consent to be in the study | week 0 |
| Retention Rate | Percentage of patients with baseline data who complete 16-week outcome assessments | 16-week outcome assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Patient weight obtained from the electronic medical record on the clinical visit date closest to the 16-week study assessment date | 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Corrine I. Voils, PhD | William S. Middleton Memorial Veterans Hospital, Madison, WI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| William S. Middleton Memorial Veterans Hospital, Madison, WI | Madison | Wisconsin | 53705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30712488 | Result | Adamek KE, Ramadurai D, Gunzburger E, Plomondon ME, Ho PM, Raghavan S. Association of Diabetes Mellitus Status and Glycemic Control With Secondary Prevention Medication Adherence After Acute Myocardial Infarction. J Am Heart Assoc. 2019 Feb 5;8(3):e011448. doi: 10.1161/JAHA.118.011448. | |
| 31999175 | Derived | Voils CI, Adler R, Strawbridge E, Grubber J, Allen KD, Olsen MK, McVay MA, Raghavan S, Raffa SD, Funk LM. Early-phase study of a telephone-based intervention to reduce weight regain among bariatric surgery patients. Health Psychol. 2020 May;39(5):391-402. doi: 10.1037/hea0000835. Epub 2020 Jan 30. |
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33 participants provided verbal consent. Of those, 3 were unable to be reached and 30 were reached by telephone to complete baseline measures and were scheduled for their first intervention phone call. Of those 30, 29 participants were reached for the first intervention phone call, and 1 participant unable to be reached for further participation.
Participants were recruited from January to March 2018. These participants were identified using electronic medical record data indicating that they had bariatric surgery for weight loss at one of four VA hospitals: West Roxbury, MA; Long Beach, CA; Palo Alto, CA; and Ann Arbor, MI.
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| ID | Title | Description |
|---|---|---|
| FG000 | Maintenance | behavioral intervention to increase adherence to lifestyle recommendations maintenance intervention: Participants will receive calls at weeks 1, 2, 3, 4, 6, 8, 10, 12, and 14 that focus on satisfaction with outcomes of behavior change, self-monitoring, relapse planning, and social support. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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30 participants completed baseline measures.
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| ID | Title | Description |
|---|---|---|
| BG000 | Maintenance | behavioral intervention to increase adherence to lifestyle recommendations maintenance intervention: Participants will receive calls at weeks 1, 2, 3, 4, 6, 8, 10, 12, and 14 that focus on satisfaction with outcomes of behavior change, self-monitoring, relapse planning, and social support. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Recruitment Rate | Percentage of contacted patients who consent to be in the study | # of patients for whom phone screening was attempted | Posted | Count of Participants | Participants | week 0 |
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16 weeks
Adverse events were volunteered by participants during intervention or assessment phone calls; they were not systematically queried in this minimal-risk intervention.
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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 | Maintenance | behavioral intervention to increase adherence to lifestyle recommendations maintenance intervention: Participants will receive calls at weeks 1, 2, 3, 4, 6, 8, 10, 12, and 14 that focus on satisfaction with outcomes of behavior change, self-monitoring, relapse planning, and social support. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Corrine Voils | William S Middleton Memorial Veterans Hospital | 608-262-9636 | corrine.voils@va.gov |
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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 | Dec 22, 2017 | Apr 17, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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All participants receive the intervention
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Primary | Retention Rate | Percentage of patients with baseline data who complete 16-week outcome assessments | Posted | Count of Participants | Participants | 16-week outcome assessment |
|
|
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| Secondary | Weight | Patient weight obtained from the electronic medical record on the clinical visit date closest to the 16-week study assessment date | The N=30 is based on the number of participants who provided baseline data according to Intent-to-treat principles | Posted | Mean | Standard Deviation | pounds | 16 weeks |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |