Nearly 78% of Veterans are overweight or obese, imposing a tremendous burden on the Veterans Health Administration (VHA) healthcare system for the treatment of obesity-related chronic disease and disability. While weight management treatment has been implemented in VHA, program data shows low enrollment, participation, and weight loss. Traditional behavioral weight loss trials frequently exclude individuals with multiple chronic health conditions. Additionally, men are less likely than women to participate in these trials. New weight loss approaches may be needed to treat these populations.
To test whether a small-changes intervention (The Aspiring to Lifelong Health Program; aka ASPIRE), delivered in groups or individually via telephone, promotes greater weight loss than standard obesity treatment in a predominantly male, high-risk Veteran population. Data were collected in 2010-13.
A three-arm, 12-month randomized pragmatic effectiveness trial was conducted. Participants were recruited from MOVE! referrals and randomly assigned to one of three programs: the 12-month ASPIRE weight loss program delivered 1) individually over the phone (ASPIRE-Phone) or 2) in-person group sessions (ASPIRE-Group); compared to 3) Veteran Health Administration's VHA standard weight loss program, MOVE!. Participants in the ASPIRE arms met with health coaches weekly in months 1-3, bi-weekly in months 4-9, and monthly in months 10-12. Usual care participants met weekly for 12 weeks with limited options for follow-up care. The ASPIRE program had distinct characteristics: 1) the opportunity for most participants to work with one lifestyle coach throughout treatment, 2) an emphasis on behavior change through a "small steps" approach; 3) the prominence of self-monitoring both physical activity and food intake as a weight loss tool; and 4) the addition of a purely phone based option. Assessments that included the collection of weight, waist circumference and lab values, along with questionnaires, were conducted at baseline, 3-months and 12-months. ASPIRE also added a follow-up component to the study, which was offered to patients at their 12-month assessment. For phone and group patients, it consisted of sessions every other month and an assessment at 18 and 24 months. Usual care patients participated in the assessments only.
Phone-based Interviews were conducted shortly after the 3-month assessment with 19 patients in the ASPIRE phone arm and with 16 in the ASPIRE group arm. These interviews were recorded, transcribed and analyzed using NVivo qualitative software to identify themes associated with successful weight loss at 3-month.
Approximately 5% of all phone and group intervention sessions were audio-recorded. An expert rater used a checklist to rate session fidelity. A second rater independently assessed 30% of the recorded sessions to establish inter-rater reliability. The checklist was psychometrically validated. It was hypothesized that greater adherence to core behavioral change processes and patient-centered communication strategies by the interventionists would be associated with higher levels of weight loss.
Using intention-to-treat principles guide all analyses. The primary outcome was weight change and secondary outcomes included changes in anthropometric (e.g., waist circumference), behavioral, fitness, psychosocial, and physiological measures. The primary analytic approach relied on a linear mixed-effects model with baseline, 3- and 12-month outcomes (e.g., weight) as dependent variables, with each subject as a random intercept to adjust for within-patient correlation of the repeated measures, fixed predictors of study arm indicators, 3- and 12-month time indicators, and time-by-study arm interactions.
481 Veterans were enrolled in this study: 162 patients in the ASPIRE-phone arm, 160 in the ASPIRE-group arm and 159 in usual care MOVE. Participants were predominantly male (85%) with a mean age of 55 years old, low socioeconomic status (22% college graduate, 41% with annual income below $20,000) and nearly balanced between minority and non-minority racial status (42% non-minority). Participants had a high burden of physical co-morbidities (mean 2.16) and mental health illness (57% with at least one diagnosis) burden. 84% of participants had pre-diabetes or diabetes. Baseline characteristics of participants were similar across the arms except for depression, substance abuse disorder and income.
Seventy-eight percent and 75% of participants completed the 3- and 12-month assessments, respectively. Sixty-nine percent of patients enrolled in the second year of the program. Of these, 87% and 86% completed the 18- and 24-month assessments, respectively.
At 3 months, participants in the two ASPIRE programs lost significant weight (p's<.01) compared to baseline. At 12 months, participants in all three arms lost significant weight compared to baseline (p's<.01); weight loss was comparable for ASPIRE-Phone and MOVE! participants (p = 0.91). However, ASPIRE-Group participants lost significantly more weight (-2.8 kg) than those in ASPIRE-Phone (-1.4 kg; p = .04) and MOVE! (-1.4 kg, p = .04). Secondary measures generally improved at 3 months. Significant improvements were more likely with the ASPIRE programs, but there were no differences between programs for any measure other than EuroQol utility, which increased more for ASPIRE-Phone participants compared to ASPIRE-Group (p=.03). At 12 months, participants in all three programs had significant improvement in life satisfaction, HDL, and functional exercise capacity (i.e., 6-minute walk distance; Table 3). At 3 and 12 months, the two ASPIRE programs resulted in lower fat intake compared to baseline, with this reduction significantly lower for ASPIRE-Group than for MOVE!. There were no other differences between arms at 12 months.
Program participation rates differed between arms. During the first three months, when the 3 programs had a comparable number (11-12) of scheduled sessions, participants completed 7.9 (7.3-8.5), 6.6 (5.9-7.3), and 3.2 (2.7-3.7) sessions in the ASPIRE-Phone, ASPIRE-Group, and MOVE! arms, respectively. Notably, fidelity checklist factors associated with high adherence to intervention content and high quality of coaching delivery were shown to have a significant association (all p's <.01) with weight outcomes at three months for participants in ASPIRE-group but not for ASPIRE phone participants.
The qualitative data demonstrates that Veterans in the ASPIRE trial experienced many barriers to weight loss, including physical and mental health comorbidities, chronic pain, limited mobility, and low socio-economic status. However, despite these barriers, many Veterans exhibited high levels of resiliency and were able to make healthy lifestyle changes.
The incremental benefits of group-based ASPIRE over the current MOVE! program could yield significant population-level benefits if implemented on a large-scale in VA. The program is being implemented at one VA in North Carolina so far. We provided training and materials and will continue to serve as consultants. This experience will be used to develop recommendations for future implementations. NCP, our operational partner, is in the process of revamping MOVE! program guidelines based, in part, on results from this trial.
- Damschroder LJ, Reardon CM, Sperber N, Robinson CH, Fickel JJ, Oddone EZ. Implementation evaluation of the Telephone Lifestyle Coaching (TLC) program: organizational factors associated with successful implementation. Translational behavioral medicine. 2017 Jun 1; 7(2):233-241.
- Janney CA, Masheb RM, Lutes LD, Holleman RG, Kim HM, Gillon LR, Damschroder LJ, Richardson CR. Mental health and behavioral weight loss: 24-month outcomes in Veterans. Journal of affective disorders. 2017 Jun 1; 215:197-204.
- Lutes LD, Damschroder LJ, Masheb R, Kim HM, Gillon L, Holleman RG, Goodrich DE, Lowery JC, Janney C, Kirsh S, Richardson CR. Behavioral Treatment for Veterans with Obesity: 24-Month Weight Outcomes from the ASPIRE-VA Small Changes Randomized Trial. Journal of general internal medicine. 2017 Apr 1; 32(Suppl 1):40-47.
- Vimalananda V, Damschroder L, Janney CA, Goodrich D, Kim HM, Holleman R, Gillon L, Lutes L. Weight loss among women and men in the ASPIRE-VA behavioral weight loss intervention trial. Obesity (Silver Spring). 2016 Sep 1; 24(9):1884-91.
- Masheb RM, Lutes LD, Kim HM, Holleman RG, Goodrich DE, Janney CA, Kirsh S, Higgins DM, Richardson CR, Damschroder LJ. Weight loss outcomes in patients with pain. Obesity (Silver Spring). 2015 Sep 1; 23(9):1778-84.
- Masheb RM, Lutes LD, Kim HM, Holleman RG, Goodrich DE, Janney CA, Kirsh S, Richardson CR, Damschroder LJ. High-frequency binge eating predicts weight gain among veterans receiving behavioral weight loss treatments. Obesity (Silver Spring). 2015 Jan 1; 23(1):54-61.
- Damschroder LJ, Lutes LD, Kirsh S, Kim HM, Gillon L, Holleman RG, Goodrich DE, Lowery JC, Richardson CR. Small-changes obesity treatment among veterans: 12-month outcomes. American journal of preventive medicine. 2014 Nov 1; 47(5):541-53.
- Lutes LD, Dinatale E, Goodrich DE, Ronis DL, Gillon L, Kirsh S, Richardson CR, Damschroder LJ. A randomized trial of a small changes approach for weight loss in veterans: design, rationale, and baseline characteristics of the ASPIRE-VA trial. Contemporary clinical trials. 2013 Jan 1; 34(1):161-72.
- Damschroder LJ. Interplay of Complex Barriers and Facilitators to Weight Loss: Lived Experiences of Veterans in the Aspire Trial. Poster session presented at: AcademyHealth Annual Research Meeting; 2015 Jun 15; Minneapolis, MN.
- Vimalananda V, Damschroder LJ, Richardson CR, Holleman R, Gillon L, Lutes L. Does Modality and Approach Matter? Effect of a small changes weight loss approach for weight loss in women and men Veterans. Poster session presented at: VA HSR&D Enhancing Partnerships for Research and Care of Women Veterans Conference; 2014 Aug 1; Washington, DC.
- Damschroder LJ, Goodrich DE, Holleman RH, Kim M, Richardson CR. Association of Mental Health Diagnoses with Weight Loss in the Aspire Trial. Paper presented at: Society of Behavioral Medicine Annual Meeting and Scientific Sessions; 2014 Apr 24; Philadelphia, PA.
- Goodrich DE, Borrelli B, Michie S, Damschroder LJ, Damschroder LJ. Systematic Fidelity Assessment to Develop More Effective Behavioral Interventions for Routine Care Settings. Paper presented at: Society of Behavioral Medicine Annual Meeting and Scientific Sessions; 2014 Apr 24; Philadelphia, PA.
- Damschroder LJ, Lowery JC. Synthesis of findings from 3 Lifestyle Behavior Change Program Implementations in VA. Paper presented at: Society of Behavioral Medicine Annual Meeting and Scientific Sessions; 2013 Mar 23; San Francisco, CA.
- Damschroder LJ, Goodrich DE, Richardson CR, Ronis DL, Lowery JC, Kirsh S, Dinatale E, Lutes LL. Measuring Fidelity to Enhance Delivery of Obesity Treatment and its Future Translation into Practice: Application in the ASPIRE-VA RCT. Paper presented at: VA HSR&D / QUERI National Meeting; 2012 Jul 19; National Harbor, MD.
- Damschroder LJ, Richardson CR, Goodrich DE, Ronis DL, Lowery JC, Kirsh S, Dinatale E, Lutes LL. Impact of a Small Changes Treatment Approach with Veterans: 3-month results from the ASPIRE-VA RCT. Poster session presented at: VA HSR&D / QUERI National Meeting; 2012 Jul 17; National Harbor, MD.
- Richardson CR, Damschroder LJ, Gillon L. Estimating the Prevalence of Undiagnosed Diabetes and Pre-diabetes in a Cohort of Overweight/Obese Veterans. Poster session presented at: AcademyHealth Annual Research Meeting; 2012 Jun 25; Orlando, FL.
- Lutes LL, Goodrich DE, Ronis DL, Kirsh S, Dinatale E, Damschroder LJ. Impact of a Small Changes Treatment Approach with Veterans: 3-month results from the ASPIRE-VA RCT. Paper presented at: Society of Behavioral Medicine Annual Meeting and Scientific Sessions; 2012 Apr 12; New Orleans, LA.
- Damschroder LJ, Goodrich DE, Gillon LR, Richardson CR, Lutes LL. Measuring fidelity to enhance delivery of obesity treatment and its future translation into practice: Application in the ASPIRE-VA small changes weight loss trial. Poster session presented at: Society of Behavioral Medicine Annual Meeting and Scientific Sessions; 2012 Apr 11; New Orleans, LA.
- Lutes LD, Damschroder LJ, Goodrich DE, Richardson CR, Gillon LR, Lowery JC. Using a Small Change Approach to Treat Obesity in Veterans: Design and Rational for the ASPIRE-VA Randomized Trial. Poster session presented at: Society of Behavioral Medicine Annual Meeting and Scientific Sessions; 2011 Apr 27; Washington, DC.
- Lutes LD, Damschroder LJ, Goodrich DE, Richardson CR, Lowery JC. Using a Small Change Approach to Treat Obesity in Veterans: Design and Rationale of the ASPIRE-VA Randomized Trial. Poster session presented at: International Congress on Obesity; 2010 Jul 11; Stockholm, Sweden.
Health Systems, Diabetes and Related Disorders, Other Conditions
Prevention, Treatment - Comparative Effectiveness
Access, Obesity, Outcomes - Patient, Self-care, Telemedicine/Telehealth