Maintaining Resistance Training in Older Prediabetic Adults

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Brenda Davy, Virginia Polytechnic Institute and State University
ClinicalTrials.gov Identifier:
NCT01112709
First received: April 22, 2010
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

The aim of this Phase II Clinical Trial is to demonstrate the efficacy of social cognitive theory (SCT) based intervention for initiating, and most importantly, maintaining resistance training in older adults with pre-diabetes (i.e., impaired glucose tolerance or impaired fasting glucose) to improve blood glucose regulation.


Condition Intervention Phase
Diabetes
Prediabetes
Behavioral: SCT-based Resistance Training exercise program
Other: Standard Intervention with minimal contact
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Maintaining Resistance Training in Older Prediabetic Adults: Theoretical Approach

Resource links provided by NLM:


Further study details as provided by Virginia Polytechnic Institute and State University:

Primary Outcome Measures:
  • Markers of prediabetes [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    glucose tolerance and fasting glucose concentration

  • Muscular Strength [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    3 RM (repetition maximum - the maximum amount of weight that can be lifted three times)


Secondary Outcome Measures:
  • Insulin secretion and action [ Time Frame: 15 Months ] [ Designated as safety issue: No ]
  • Adherence to the resistance training program session schedule (twice/week sessions) [ Time Frame: 15 Months ] [ Designated as safety issue: No ]
  • Social Cognitive Theory Measures (includes self-efficacy, self-regulation, outcome expectancies, and affect; related to resistance training) [ Time Frame: 15 Months ] [ Designated as safety issue: No ]
  • Body Composition [ Time Frame: 15 Months ] [ Designated as safety issue: No ]

Enrollment: 170
Study Start Date: January 2011
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SCT
This arm is a long-term, Social Cognitive Theory (SCT)-based intervention, emphasizing self-regulation and other SCT strategies to optimize training, with faded contact.
Behavioral: SCT-based Resistance Training exercise program
Two supervised RT sessions per week for the first 3 months, then a self-monitored RT phase for the remainder of the study, with primarily Internet-based contact.
Active Comparator: Control
This arm will be the "control" condition; a Standard intervention with minimal contact.
Other: Standard Intervention with minimal contact
This is the control condition for comparison; the approach will be identical to the experimental condition, but without the theoretical components (skills to increase self efficacy for RT, self regulation for RT). Contact with the study staff will be reduced from that received by the experimental group.

Detailed Description:

The aim of this Phase II Clinical Trial is to demonstrate the efficacy of social cognitive theory (SCT) based intervention for initiating, and most importantly, maintaining resistance training in older adults with pre-diabetes (i.e., impaired glucose tolerance or impaired fasting glucose) to improve glucose homeostasis. The overall aim is consistent with NIDDK's Behavioral/Prevention Research Program's focus on individual, family, and community-based strategies for prevention of diabetes and its complications. Resistance training is particularly applicable to older, pre-diabetic adults given the loss of lean body mass and worsening of glucose tolerance with aging. The proposed research program evaluates a 15-month SCT based intervention for maintenance of resistance training with older adults. Men and women 50-69 (N=180) with pre-diabetes, defined as exhibiting either impaired glucose tolerance (IGT; 2-h glucose 140-199 mg/dl) or impaired fasting glucose (IFG; 100-125 mg/dl), will first follow the same standard, supervised 3-month initiation period with resistance training. All people completing the Initial Phase will be randomly assigned to 1 of 2 maintenance conditions: 1. a long-term SCT based, ASPIRE intervention, emphasizing self-regulation and other SCT strategies to optimize training, with faded contact; 2. a Standard intervention with minimal contact. The primary outcome measures are indices of pre-diabetes (glucose tolerance and fasting glucose concentration) and strength. Secondary measures include adherence; ß-cell responsivity, insulin sensitivity, and disposition index, as determined by the oral glucose and C-peptide minimal model; fat free mass, other indicators of health and metabolic fitness, and SCT measures. Assessments will occur at baseline, at the end of the Initiation Phase (3 months), at the end of the different interventions (9 months) and 6 months after all contact has ended (15 months from baseline). It is hypothesized that SCT based resistance training with faded contact will produce better outcomes than the Standard-based resistance training at 9 month and 15 month assessments. It also is hypothesized that improvements in glucose homeostasis and in strength from resistance training will be mediated by adherence, self-efficacy, and use of self-regulation strategies. Resistance training has become an important component in the treatment and prevention of diseases and disabilities, and especially so for Type 2 diabetes. Critical to public health and a focus of NIDDK are theory-based interventions that enable, effective long-term resistance training with minimal supervision after an initiation phase and where improvements in adherence and outcomes are facilitated by theoretical constructs.

  Eligibility

Ages Eligible for Study:   50 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • prediabetes,
  • overweight or obese,
  • aged 50-69 years,
  • otherwise good health,
  • physician clearance for exercising,
  • sedentary (< 150 min/wk of moderate intensity physical activity).

Exclusion Criteria:

  • diagnosed with diabetes or other conditions that would preclude an individual from safely resistance training (eg, heart disease),
  • currently engaging in RT (for > 1 year),
  • smokers,
  • uncontrolled hypertension,
  • retinopathy,
  • recent cataract surgery,
  • recent head trauma.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01112709

Locations
United States, Virginia
Virginia Tech
Blacksburg, Virginia, United States, 24061
VT Riverside
Roanoke, Virginia, United States, 24016
Sponsors and Collaborators
Virginia Polytechnic Institute and State University
Investigators
Principal Investigator: Brenda M Davy, PhD, RD Virginia Polytechnic Institute and State University
Principal Investigator: Richard A Winett, PhD Virginia Polytechnic Institute and State University
  More Information

No publications provided

Responsible Party: Brenda Davy, Associate Professor, Virginia Polytechnic Institute and State University
ClinicalTrials.gov Identifier: NCT01112709     History of Changes
Other Study ID Numbers: 1R01DK082383-01A1, R01DK082383
Study First Received: April 22, 2010
Last Updated: March 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Polytechnic Institute and State University:
Diabetes
Prediabetes
Resistance training
behavior
behavioral change theory

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Intolerance
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia

ClinicalTrials.gov processed this record on April 15, 2014