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Randomized Controlled Trial
. 2017 Jun;7(2):371-378.
doi: 10.1007/s13142-016-0447-z.

The healthy living partnerships to prevent diabetes and the diabetes prevention program: a comparison of year 1 and 2 intervention results

Mara Z Vitolins  1 , Scott P Isom  2 , Caroline S Blackwell  2 , Donna Kernodle  3 , Joyce M Sydell  3 , Carolyn F Pedley  4 , Jeffrey A Katula  5 , L Douglas Case  2 , David C Goff Jr  2
Affiliations
Randomized Controlled Trial

The healthy living partnerships to prevent diabetes and the diabetes prevention program: a comparison of year 1 and 2 intervention results

Mara Z Vitolins et al. Transl Behav Med. 2017 Jun.

Abstract

A number of research studies have attempted to translate the behavioral lifestyle intervention delivered in the Diabetes Prevention Program (DPP). To compare the active interventions of two trials, Diabetes Prevention Program DPP and Healthy Living Partnerships to Prevent Diabetes (HELP PD), after 1 and 2 years of intervention. DPP included 3234 adults with prediabetes randomized to intensive lifestyle intervention, metformin, troglitazone, or placebo. The lifestyle intervention, professionally delivered to individuals in a clinical setting, focused on diet and increased physical activity. HELP PD, a community-based translation of DPP, included 301 adults randomized to receive intensive lifestyle intervention or enhanced usual care. Mean weight-losses at 1 year (6.9 kg in DPP, 6.4 kg in HELP PD) and 2 years (5.5 kg in DPP, 4.4 kg in HELP PD) were similar across studies. Reductions in glucose were also similar across studies at both time points (5.2 mg/dL in DPP and 4.1 mg/dL in HELP PD at 1 year; 1.8 mg/dL and 1.6 mg/dL at 2 years). HELP PD participants achieved larger reductions in triglycerides at 1 and 2 years (38.4 mg/dL and 34.9 mg/dL, respectively) than DPP participants (24.8 mg/dL and 22.4 mg/dL). High-density lipoprotein decreased in HELP PD participants at year 1 (-0.6 mg/dL) and increased in DPP (1.2 mg/dL) but there were no significant differences in year 2. HELP PD, a community model for diabetes prevention, was similar to DPP in reducing body weight and lowering blood glucose, both important risk factors that should be controlled to reduce risk for developing type 2 diabetes.

Trial registration: ClinicalTrials.gov NCT00631345.

Keywords: Behavioral lifestyle intervention; Diabetes prevention; Translation research.

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Conflict of interest statement

Conflict of interest

No conflicts of interest, financial or otherwise, were reported by the authors of this paper.

Previous reporting of data

This manuscript has not been previously published and is not under consideration in the same or substantially similar form in any other peer-reviewed media. Other manuscripts from the HELP PD study include: design, recruitment and baseline characteristics, one and2-year fasting glucose, insulin, and adiposity outcomes, and cost, with an additional manuscript under review reporting 2-year outcomes related to the metabolic syndrome.

Data access

The authors of this manuscript had full control of the data used to perform the analyses described herein and agree to allow Translational Behavioral Medicine to review the data if so requested.

Ethics approval and consent to participate

The HELP PD study was reviewed and approved by the Institutional Review Board (IRB) no. 2 of Wake Forest University Health Sciences (IRB00000613) and all participants were required to sign an informed consent document prior to participation. All procedures were conducted in accordance with the ethical standards of the IRB of Wake Forest University Health Sciences and all local, state, and national regulations regarding the protection of human subjects.

Welfare of animals

Not applicable. The studies described in this manuscript were conducted only in humans; no data was collected from animals.

Figures

Fig. 1
Fig. 1
a Weight loss in HELP and DPP at 1 year. p values for study differences of weight loss at 1 year in the intervention arms of the study come from a logistic regression model which adjusts for baseline weight: weight loss category = baseline weight + study. DPP n = 995; HELP n = 133. b Weight loss in HELP and DPP at year 2. p values for study differences of weight loss at 2 years in the intervention arms of the study come from a logistic regression model which adjusts for baseline weight: Weight loss category = Baseline weight + Study. DPP n = 930; HELP n = 125
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