Planned care for obesity and cardiovascular risk reduction using a stepped-down approach: A randomized-controlled trial

Prev Med. 2018 Sep;114:223-231. doi: 10.1016/j.ypmed.2018.07.015. Epub 2018 Jul 25.

Abstract

Primary care-based approaches to address concurrent obesity and cardiovascular disease risk factors (CVDRFs) that begin with a high intensity intervention that is subsequently decreased (i.e., stepped-down) if weight loss is achieved have not been rigorously examined. Our study is a 20-month, single-blind randomized controlled trial at five primary care clinics in San Diego, CA, in 2013, where 262 obese adults (aged 25-70 years; 32.1% male; 59.2% white) with at least one CVDRF were enrolled into planned care for obesity and risk reduction (PCORR) using a stepped-down approach or enhanced usual care (EUC). All patients received physician recommendations for weight loss and CVDRFs. EUC patients (n = 132) received an individual session with a health educator every 4 months. PCORR patients (n = 130) received individual and group sessions (in-person, mail, telephone, and email) in three steps, characterized by less contact if success was achieved. At 20 months, 40.7%, 23.8%, and 15.4% of PCORR patients were in steps 1, 2, and 3, respectively (25.2% were lost to follow-up). PCORR resulted in a between-group difference in reduction in body weight of 6.1% [95% CI, 5.3 to 6.9] compared to EUC 2.8% [95% CI, 2.0 to 3.6] p = 0.007, with a greater reduction in BMI (35.2 [95% CI, 34.4 to 35.9] to 33.7 [95% CI, 32.9 to 34.5] kg/m2) than EUC (36.0 [95% CI, 35.3 to 36.8] to 35.1 [95% CI, 34.3 to 35.9] kg/m2), as indicated by a significant treatment by time interaction (p = 0.009). PCORR resulted in greater weight loss over 20 months than EUC.

Trial registration: ClinicalTrials.gov, NCT01134029.

Keywords: Cardiovascular disease risk factors; Obesity; Randomized controlled trial; Weight loss.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adult
  • Aged
  • Body Mass Index
  • California
  • Cardiovascular Diseases / prevention & control*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Obesity / therapy*
  • Primary Health Care
  • Risk Factors
  • Risk Reduction Behavior*
  • Single-Blind Method
  • Weight Loss*

Associated data

  • ClinicalTrials.gov/NCT01134029