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The Healthy Living Partnerships to Prevent Diabetes study: 2-year outcomes of a randomized controlled trial
Katula JA, Vitolins MZ, Morgan TM, Lawlor MS, Blackwell CS, Isom SP, Pedley CF, Goff DC Jr
American Journal of Preventive Medicine 2013 Apr;44(4 Suppl 4):S324-S332
clinical trial
6/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Since the Diabetes Prevention Project (DPP) demonstrated that lifestyle weight-loss interventions can reduce the incidence of diabetes by 58%, several studies have translated the DPP methods to public health-friendly contexts. Although these studies have demonstrated short-term effects, no study to date has examined the impact of a translated DPP intervention on blood glucose and adiposity beyond 12 months of follow-up. PURPOSE: To examine the impact of a 24-month, community-based diabetes prevention program on fasting blood glucose, insulin, insulin resistance as well as body weight, waist circumference, and BMI in the second year of follow-up. DESIGN: An RCT comparing a 24-month lifestyle weight-loss program (LWL) to an enhanced usual care condition (UCC) in participants with prediabetes (fasting blood glucose 95 to 125 mg/dL). Data were collected in 2007 to 2011; analyses were conducted in 2011 to 2012. SETTING/PARTICIPANTS: 301 participants with prediabetes were randomized; 261 completed the study. The intervention was held in community-based sites. INTERVENTION: The LWL program was led by community health workers and sought to induce 7% weight loss at 6 months that would be maintained over time through decreased caloric intake and increased physical activity. The UCC received two visits with a registered dietitian and a monthly newsletter. MAIN OUTCOME MEASURES: The main measures were fasting blood glucose, insulin, insulin resistance, body weight, waist circumference, and BMI. RESULTS: Intent-to-treat analyses of between-group differences in the average of 18- and 24-month measures of outcomes (controlling for baseline values) revealed that the LWL participants experienced greater decreases in fasting glucose (-4.35 mg/dL); insulin (-3.01 muU/ml); insulin resistance (-0.97); body weight (-4.19 kg); waist circumference (-3.23 cm); and BMI (-1.40), all p-values < 0.01. CONCLUSIONS: A diabetes prevention program administered through an existing community-based system and delivered by community health workers is effective at inducing significant long-term reductions in metabolic indicators and adiposity. TRIAL REGISTRATION: This study is registered at ClinicalTrials.gov NCT00631345.

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