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PPO 16-331 – HSR Study

PPO 16-331
Development of a Weight Maintenance Intervention for Bariatric Surgery Patients
Corrine I. Voils, PhD
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, WI
Funding Period: August 2017 - July 2018
The VA performs approximately 500 bariatric operations per year across 17-21 sites. In a recent State-of-the-Art Conference on weight management co-led by Health Services Research and Development (HSR&D) and by our operations partner, the National Center for Health Promotion and Disease Prevention (NCP), the bariatric surgery committee strongly agreed that future priorities for VA include increasing the number of sites that offer bariatric surgery and identifying strategies to help Veterans maintain weight loss resulting from surgery. Our intervention, if effective, can help increase VHA's return on investment as the bariatric surgery volume increases over the next decade.

The project objectives are as follows:

1) Refine telephone intervention scripts to address dietary, mobility, and behavioral issues specific to bariatric surgery patients.

2) Evaluate feasibility of conducting a multi-site trial, as indicated by recruitment and outcome assessment rates.

3) Evaluate intervention acceptability, as indicated by intervention adherence rates, pre-post changes in weight and process measures, and feedback from post-intervention qualitative interviews.

Eligible patients received a recruitment letter from study staff at the Madison VAMC. One to two weeks after recruitment letters were mailed, the project coordinator (PC) called patients to describe the study, obtain telephone consent, and schedule the baseline measures call. The baseline call began with a 24-hour diet recall administered by a trained staff member, then moved on to several baseline measures administered orally; patients were then scheduled for their first intervention call. Following the baseline telephone call, patients received phone calls weekly for the first month (Weeks 1, 2, 3, 4) and biweekly for months 2-4 (Weeks 6, 8, 10, 12, 14).

The first four calls focused on diet, physical activity, and supplement adherence content specific to post-bariatric surgery patients. Each subsequent call addressed maintenance skill building and anticipatory problem solving using the MAINTAIN protocol which includes discussing: Satisfaction with outcomes of behavior change, self-monitoring, recovery self efficacy/relapse planning, and primary source of support is social network.

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.

Dietary intake was assessed with a multiple pass 24-hour diet recall. Daily physical activity was assessed by the short version of the International Physical Activity Questionnaire (IPAQ).

Lastly, post-intervention qualitative interviews assessed patients' experience with the intervention. Semi-structured qualitative interviews were conducted via telephone within four weeks of the final outcome assessment by Dr. Voils or other trained study staff. A semi-structured interview guide was created, organized around the theoretical constructs indicated in our model.

The feasibility of conducting an adequately powered RCT was evaluated by: 1. the accuracy of our data pull algorithm compared to chart review and site operative lists; 2. recruitment rate (our a priori criterion was 25%, which would be required to enroll a sufficient number of patients into an RCT); 3. outcome retention rate (our a priori criterion was 80% as this is a commonly accepted criterion for weight loss RCTs); and 4. intervention adherence rate. To facilitate delivery of the intervention over the short funding period and keep the workload manageable for the registered dietician (RD), we decided to conduct the pilot study in three cohorts of 10 patients each. As one cohort transitioned from weekly to biweekly calls, we recruited the next cohort.

1. Accuracy of data pull algorithm: We validated our data pull algorithm by comparing it to chart review and to site operative lists for the enrollment period from three sites. Chart review of all patients identified in the data pull resulted in the exclusion of 47 patients who did not receive primary bariatric surgery (i.e., surgery was for cancer or was a revisional bariatric procedure). The site operative lists identified additional patients who received surgery who were not captured by the data pull. After chart review, however, these patients were deemed ineligible for our study because they had a revisional bariatric procedure. Taken together, these findings underscore the necessity of conducting chart review to ensure receipt of primary bariatric surgery.

2. Recruitment rate: We mailed recruitment letters to 81 patients. Of the 69 patients for whom telephone screening was attempted, we obtained consent from 33 (recruitment rate 48%), baseline measures from 30 (43%), and started 29 (42%) on the intervention. Among the 30 participants with baseline measures, the average age was 56.9 years [standard deviation (SD) 10.0], 73% were White, and 80% were male.

3. Retention rate: We were able to reach 28 (93%) of participants who were due for 16-week follow-up telephone assessments.

4. Intervention adherence rate: The mean number of intervention calls received (of 9) was 7.8. Participants who received < 9 calls missed calls due to the difficulty of scheduling weekly calls rather than dropout/withdrawal from the intervention.

Severe obesity affects over 770,000 Veterans and is increasing in prevalence. The VA performs ~500 bariatric surgeries per year, yet neither bariatric programs nor MOVE! are currently designed to provide the long-term support patients need to sustain recommended lifestyle changes. Many Veterans live hours away from the center where they receive their surgery. For example, the VA's Palo Alto bariatric program recently reported that their patients live an average of 236 miles from their medical center, and participants in our pilot lived up to 5 hours from the medical center where they received surgery. Accordingly, an effective intervention is needed that can be delivered remotely. Our intervention is designed to be integrated into existing systems (e.g., it could be offered by a registered dietician (RD) in the Nutrition Service or within MOVE! infrastructure, either locally or nationally). The VA has long been a model healthcare system for implementation of centralized services via telemedicine. By offering post-surgical counseling for bariatric surgery patients to geographically dispersed patients, we are establishing a model that could be adapted by academic and community practices that individually lack the resources to offer long-term behavioral counseling for patients.

External Links for this Project

NIH Reporter

Grant Number: I21HX002295-01

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Journal Articles

  1. 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. Journal of the American Heart Association. 2019 Feb 5; 8(3):e011448. [view]
  2. 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 psychology : official journal of the Division of Health Psychology, American Psychological Association. 2020 May 1; 39(5):391-402. [view]

DRA: Other Conditions
DRE: Prevention, Treatment - Efficacy/Effectiveness Clinical Trial, TRL - Applied/Translational
Keywords: none
MeSH Terms: none

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