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IBB 09-034 – HSR Study

 
IBB 09-034
ASPIRE: Coaching Veterans to Healthy Weights and Wellness
Julie C. Lowery, PhD MHSA
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, MI
Funding Period: October 2009 - December 2013
BACKGROUND/RATIONALE:
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.

OBJECTIVE(S):
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.

METHODS:
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.

FINDINGS/RESULTS:
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.

IMPACT:
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.


External Links for this Project

NIH Reporter

Grant Number: I01HX000148-01
Link: https://reporter.nih.gov/project-details/7748628

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PUBLICATIONS:

None at this time.


DRA: Health Systems, Diabetes and Other Endocrine Conditions, Other Conditions
DRE: Prevention, Treatment - Comparative Effectiveness
Keywords: Access, Obesity, Self-care
MeSH Terms: none

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