Clinical trial NCT01112709: Maintaining Resistance Training in Older Prediabetic Adults
Official title: Maintaining Resistance Training in Older Prediabetic Adults: Theoretical Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes
Prediabetes
Keywords: Diabetes
Prediabetes
Resistance training
behavior
behavioral change theory
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2010-04-28
Enrollment: 170
Sex: ALL
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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 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.

Primary outcomes:
measure: Markers of prediabetes
timeFrame: 15 months
measure: Muscular Strength
timeFrame: 15 months
Secondary outcomes:
measure: Insulin secretion and action
timeFrame: 15 Months
measure: Adherence to the resistance training program session schedule (twice/week sessions)
timeFrame: 15 Months
measure: Social Cognitive Theory Measures (includes self-efficacy, self-regulation, outcome expectancies, and affect; related to resistance training)
timeFrame: 15 Months
measure: Body Composition
timeFrame: 15 Months
Other outcomes:
Locations:
city: Blacksburg
country: United States
facility: Virginia Tech
state: Virginia
city: Roanoke
country: United States
facility: VT Riverside
state: Virginia
Study officials:
affiliation: Virginia Polytechnic Institute and State University
name: Brenda M Davy, PhD, RD
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Polytechnic Institute and State University
name: Richard A Winett, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Davy BM, Winett RA, Savla J, Marinik EL, Baugh ME, Flack KD, Halliday TM, Kelleher SA, Winett SG, Williams DM, Boshra S. Resist diabetes: A randomized clinical trial for resistance training maintenance in adults with prediabetes. PLoS One. 2017 Feb 23;12(2):e0172610. doi: 10.1371/journal.pone.0172610. eCollection 2017.
citation: Eikenberg JD, Savla J, Marinik EL, Davy KP, Pownall J, Baugh ME, Flack KD, Boshra S, Winett RA, Davy BM. Prediabetes Phenotype Influences Improvements in Glucose Homeostasis with Resistance Training. PLoS One. 2016 Feb 3;11(2):e0148009. doi: 10.1371/journal.pone.0148009. eCollection 2016.
citation: Halliday TM, Davy BM, Clark AG, Baugh ME, Hedrick VE, Marinik EL, Flack KD, Savla J, Winett S, Winett RA. Dietary intake modification in response to a participation in a resistance training program for sedentary older adults with prediabetes: findings from the Resist Diabetes study. Eat Behav. 2014 Aug;15(3):379-82. doi: 10.1016/j.eatbeh.2014.04.004. Epub 2014 May 10.