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IIR 11-040 – HSR&D Study

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IIR 11-040
Maintenance After Initiation of Nutrition TrAINing (MAINTAIN)
Corrine I. Voils PhD
Durham VA Medical Center, Durham, NC
Durham, NC
Funding Period: May 2012 - October 2015

BACKGROUND/RATIONALE:
Obesity is the second leading cause of preventable deaths in the United States and is associated with a wide range of diseases. Most patients who achieve weight loss regain much of this weight within a year. The MAINTAIN intervention was developed to slow the rate of weight regain following weight loss.

OBJECTIVE(S):
The current study examined the effectiveness of a weight loss maintenance program following initial weight loss among obese veterans.

Specific Aims were to:
Aim 1: Compare mean net weight loss in the maintenance group with the usual care group at the end of the study period.
Aim 2: Compare the mean improvement in caloric intake in the maintenance group versus the usual care group at the end of the study period.
Aim 3: Compare the mean improvement in physical activity in the maintenance group with the usual care group at the end of the study period.
Aim 4: Examine the cost effectiveness of the maintenance intervention compared to usual care.

METHODS:
Veterans aged 75 years or less with a body mass index of 30 kg/m2 or higher participated in a 16-week group-based weight loss program. Participants who lost at least 4 kg were randomized to receive (a) usual care for 56 weeks or (b) maintenance intervention for 42 weeks, followed by 14 weeks of no intervention contact. The maintenance intervention involved three in-person group visits and transitioned to individualized telephone calls. Weights were multiply imputed using Markov chain Monte Carlo under a general multivariate normal model. Then, a longitudinal data model including weights at week 0 and week 56 was fit; predictors included the week 56 time indicator, treatment arm by time interaction, and the stratification variable of amount of weight change during the 16-week weight loss phase. Linear mixed models (LMMs) were used to analyze caloric intake with time indicators for weeks 26 and 56, the treatment arm by time interaction, and the stratification variable. Generalized LMMs were fit using a negative binomial distribution and log link function to examine minutes of physical activity per week; independent variables were identical to those included in the caloric intake model.

FINDINGS/RESULTS:
Telephone screen attempts were made for 1130 patients, of which 685 were scheduled for in-person consent and screening. Of the 504 participants who provided a weight for the first initiation group session, 148 were lost to follow-up, 52 withdrew, 82 failed to lose at least 4 kg, and 222 lost at least 4 kg and were randomized (110 maintenance intervention, 112 usual care). Retention was 80% for the maintenance intervention and 90% for usual care. Attendance at the three maintenance group meetings ranged from 0-3, mean(M)=2.07, standard deviation (SD)=1.06. Participation in the eight maintenance telephone calls ranged from 2-8, M=7.34, SD=1.43. Retention for 56-week assessments in the usual care and maintenance arms were 90% and 80% for weight, 78% and 76% for FFQ, and 89% and 79% for IPAQ.

The maintenance group only regained 0.74 kg during the 56-week intervention period, whereas the usual care group regained 2.36 kg. This treatment difference was statistically significant (estimated mean: -1.61 (95% confidence interval (CI): 0.07, 3.13, p=.04). A statistically significant difference in self-reported energy intake (kcal) was noted between the maintenance (estimated mean 1176.06) and usual care (estimated mean 1399.50) groups at week 26 (estimated mean difference -223.44; 95% CI: -395.92, -50.96; p=0.01). However, the between-group difference was no longer statistically significant at 56 weeks (estimated means: maintenance, 1226.84; usual care, 1352.34; estimated mean difference: -125.49; 95% CI: -280.71, 29.72; p=0.11). There were no differences in estimated rates of walking or moderate physical activity among the maintenance group relative to the usual care group at week 26 (walking IRR: 1.38; 95% CI: 0.85, 2.23; p=0.19; moderate IRR: 1.01; 95% CI: 0.54, 1.90; p=0.96) or week 56 (walking IRR: 1.03; 95% CI: 0.63, 1.68; p=0.91; moderate IRR: 1.07; 95% CI: 0.57, 2.03; p=0.83).

Aggregate labor and capital costs for delivering the intervention were generated from activity logs of interventionists and market rates for capital costs. Labor costs were calculated as the product of the time reported on the activity logs and hourly wage derived from interventionist salaries from the General Schedule salary table for Durham. Intervention cost was $88.58 per participant for the group-based initiation intervention and $276.19 per participant for the individual maintenance intervention. There were no differences in mean and median VA total expenditures by group during the 56 week maintenance phase [(maintenance group mean $11,932 (SD=$20,714), usual care mean $14,876 (SD=$32,795), p=0.42; maintenance group median $4,292 (IQR=$13,429), usual care median $5,584 (IQR=$11,438), p=0.37].

IMPACT:
The next step in this program of research is to refine the intervention to help patients maintain weight loss following weight loss surgery. Ultimately, sustained weight loss could reduce obesity-related health care utilization and costs.

PUBLICATIONS:

Journal Articles

  1. Taylor SS, Olsen MK, McVay MA, Grubber J, Gierisch JM, Yancy WS, Voils CI. The role of group cohesion in a group-based behavioral weight loss intervention. Journal of behavioral medicine. 2019 Feb 1; 42(1):162-168.
  2. McVay MA, Yancy WS, Bennett GG, Jung SH, Voils CI. Perceived barriers and facilitators of initiation of behavioral weight loss interventions among adults with obesity: a qualitative study. BMC public health. 2018 Jul 11; 18(1):854.
  3. Funk LM, Grubber JM, McVay MA, Olsen MK, Yancy WS, Voils CI. Patient predictors of weight loss following a behavioral weight management intervention among US Veterans with severe obesity. Eating and Weight Disorders : EWD. 2018 Oct 1; 23(5):587-595.
  4. Voils CI, Olsen MK, Gierisch JM, McVay MA, Grubber JM, Gaillard L, Bolton J, Maciejewski ML, Strawbridge E, Yancy WS. Maintenance of Weight Loss After Initiation of Nutrition Training: A Randomized Trial. Annals of internal medicine. 2017 Apr 4; 166(7):463-471.
  5. Voils CI, Grubber JM, McVay MA, Olsen MK, Bolton J, Gierisch JM, Taylor SS, Maciejewski ML, Yancy WS. Recruitment and Retention for a Weight Loss Maintenance Trial Involving Weight Loss Prior to Randomization. Obesity science & practice. 2016 Dec 1; 2(4):355-365.
  6. Voils CI, Gierisch JM, Olsen MK, Maciejewski ML, Grubber J, McVay MA, Strauss JL, Bolton J, Gaillard L, Strawbridge E, Yancy WS. Study design and protocol for a theory-based behavioral intervention focusing on maintenance of weight loss: the Maintenance After Initiation of Nutrition TrAINing (MAINTAIN) study. Contemporary clinical trials. 2014 Sep 1; 39(1):95-105.
  7. Voils CI, Gierisch JM, Yancy WS, Sandelowski M, Smith R, Bolton J, Strauss JL. Differentiating Behavior Initiation and Maintenance: Theoretical Framework and Proof of Concept. Health education & behavior : the official publication of the Society for Public Health Education. 2014 Jun 1; 41(3):325-36.
Conference Presentations

  1. Voils CI, Olsen MK, Gierisch JM, Grubber J, McVay M, Bolton J, Gaillard L, Maciejewski ML, Yancy WS. Weight outcome from the Maintenance After Initiation of Nutrition Training (MAINTAIN) trial. Presented at: Society of Behavioral Medicine Annual Meeting and Scientific Sessions; 2016 Apr 1; Washington, DC.
  2. Funk LM, McVay M, Olsen MK, Grubber J, Yancy WS, Voils CI. Psychosocial predictors of weight loss following a behavioral weight management intervention among Veterans with severe obesity. Poster session presented at: Obesity Society Annual Scientific Meeting; 2015 Nov 4; New Orleans, LA.
  3. Voils CI, Grubber J, Olsen MK, McVay M. Predictors of Initiation of a behavioral weight loss program. Poster session presented at: Obesity Society Annual Scientific Meeting; 2015 Nov 2; Los Angeles, CA.
  4. Kiernan M, Leahey T, Tate D, Voils CI. Evidence-based strategies that improve recruitment, adherence and retention of randomized trials. Paper presented at: Society of Behavioral Medicine Annual Meeting and Scientific Sessions; 2015 Apr 22; San Antonio, TX.
  5. McVay M, Yancy WS, Scott CN, Allen S, McSherry WC, Voils CI. Identifying factors to target to increase initiation of behavioral weight loss treatment. Poster session presented at: Society of Behavioral Medicine Annual Meeting and Scientific Sessions; 2015 Apr 22; San Antonio, TX.
  6. Voils CI, Gierisch JM, McVay M, Maciejewski ML, Olsen MK, Yancy WS. Predictors of initiation and retention in a run-in phase to determine eligibility for a weight maintenance phase. Poster session presented at: Society of Behavioral Medicine Annual Meeting and Scientific Sessions; 2015 Apr 22; San Antonio, TX.
  7. Voils CI, Grubber J, Olsen MK, McVay M, Gierisch JM, Maciejewski ML, Yancy WS. Predictors of initiation of a behavioral weight loss intervention. Poster session presented at: Obesity Society Annual Scientific Meeting; 2014 Nov 4; Boston, MA.
  8. Yancy WS. Taking Dietary Fat Out of the Fire. Paper presented at: Virginia Commonwealth University School of Medicine Quarterly Meeting; 2012 Feb 2; Richmond, VA.


DRA: Health Systems, Other Conditions
DRE: Treatment - Efficacy/Effectiveness Clinical Trial, Treatment - Comparative Effectiveness
Keywords: Exercise, Health Promotion and Education, Outcomes - Patient, Physical Activity, Self-Care
MeSH Terms: none

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