Maintaining Resistance Training in Older Prediabetic Adults

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Maintaining Resistance Training in Older Prediabetic Adults: Theoretical Approach

Conditions
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Diabetes, Prediabetes

Intervention / Treatment
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* Behavioral: SCT-based Resistance Training exercise program
* Other: Standard Intervention with minimal contact


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SCT<br>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<br>* 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.<br>|
| Active Comparator: Control<br>This arm will be the control condition; a Standard intervention with minimal contact. | Other: Standard Intervention with minimal contact<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Markers of prediabetes | glucose tolerance and fasting glucose concentration | 15 months | 
| Muscular Strength | 3 RM (repetition maximum - the maximum amount of weight that can be lifted three times) | 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin secretion and action |  | 15 Months | 
| Adherence to the resistance training program session schedule (twice/week sessions) |  | 15 Months | 
| Social Cognitive Theory Measures (includes self-efficacy, self-regulation, outcome expectancies, and affect; related to resistance training) |  | 15 Months | 
| Body Composition |  | 15 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Prediabetes, Resistance training, behavior, behavioral change theory