title: 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.
abstract: BACKGROUND
  Obesity is a significant public health problem. Although various lifestyle approaches are effective for inducing significant weight loss, few effective behavioral weight maintenance strategies have been identified. It has been proposed that behavior maintenance is a distinct state that involves different psychological processes and behavioral skills than initial behavior change. Previously, we created a conceptual model that distinguishes behavior initiation from maintenance. This model was used to generate Maintenance After Initiation of Nutrition TrAINing (MAINTAIN), an intervention to enhance weight loss maintenance following initiation. The effectiveness of MAINTAIN is being evaluated in an ongoing trial, the rationale and procedures of which are reported herein.
  
  
  METHODS
  Veterans aged ≤ 75 with body mass index ≥ 30 kg/m(2) participate in a 16-week, group-based weight loss program. Participants who lose ≥ 4 kg by the end of 16 weeks (target n = 230) are randomized 1:1 to receive (a) usual care for 56 weeks or (b) MAINTAIN, a theoretically-informed weight loss maintenance intervention for 40 weeks, followed by 16 weeks of no intervention contact. MAINTAIN involves 3 in-person group visits that transition to 8 individualized telephone calls with decreasing contact frequency. MAINTAIN focuses on satisfaction with outcomes, weight self-monitoring, relapse prevention, and social support. We hypothesize that, compared to usual care, MAINTAIN will result in at least 3.5 kg less regain and better relative levels of caloric intake and physical activity over 56 weeks, and that it will be cost-effective.
  
  
  CONCLUSIONS
  If effective, MAINTAIN could serve as a model for redesigning existing weight loss programs.
  
  
  BACKGROUND
  NCT01357551.
authors.affiliation: Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, NC, USA; Department of Medicine, Duke University Medical Center, Durham, NC, USA.
authors.forename: Corrine I
authors.initials: CI
authors.lastname: Voils
authors.affiliation: Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, NC, USA; Department of Medicine, Duke University Medical Center, Durham, NC, USA.
authors.forename: Jennifer M
authors.initials: JM
authors.lastname: Gierisch
authors.affiliation: Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, NC, USA; Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC, USA.
authors.forename: Maren K
authors.initials: MK
authors.lastname: Olsen
authors.affiliation: Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, NC, USA; Department of Medicine, Duke University Medical Center, Durham, NC, USA.
authors.forename: Matthew L
authors.initials: ML
authors.lastname: Maciejewski
authors.affiliation: Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, NC, USA.
authors.forename: Janet
authors.initials: J
authors.lastname: Grubber
authors.affiliation: Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, NC, USA.
authors.forename: Megan A
authors.initials: MA
authors.lastname: McVay
authors.affiliation: Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, NC, USA; Department of Psychiatry, Duke University Medical Center, Durham, NC, USA.
authors.forename: Jennifer L
authors.initials: JL
authors.lastname: Strauss
authors.affiliation: Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, NC, USA.
authors.forename: Jamiyla
authors.initials: J
authors.lastname: Bolton
authors.affiliation: Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, NC, USA.
authors.forename: Leslie
authors.initials: L
authors.lastname: Gaillard
authors.affiliation: Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, NC, USA.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Strawbridge
authors.affiliation: Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, NC, USA; Department of Medicine, Duke University Medical Center, Durham, NC, USA.
authors.forename: William S
authors.initials: WS
authors.lastname: Yancy
mesh_terms: D000328:Adult; D000368:Aged; D001521:Behavior Therapy / Q000379:methods*; D015992:Body Mass Index; D001837:Body Weights and Measures; D004032:Diet; D015444:Exercise; D005260:Female; D015438:Health Behavior; D006801:Humans; D008019:Life Style; D008297:Male; D008875:Middle Aged; D044623:Nutrition Therapy / Q000379:methods*; D009765:Obesity / Q000523:psychology / Q000628:therapy*; D017060:Patient Satisfaction; D012107:Research Design; D012944:Social Support; D014481:United States; D014493:United States Department of Veterans Affairs; D061217:Weight Reduction Programs / Q000191:economics / Q000458:organization & administration*
keywords: Behavioral intervention; Maintenance; Obesity; Randomized controlled trial