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Maintaining Resistance Training in Older Prediabetic Adults

Primary Purpose

Diabetes, Prediabetes

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SCT-based Resistance Training exercise program
Standard Intervention with minimal contact
Sponsored by
Virginia Polytechnic Institute and State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes focused on measuring Diabetes, Prediabetes, Resistance training, behavior, behavioral change theory

Eligibility Criteria

50 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Virginia Tech
  • VT Riverside

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SCT

Control

Arm Description

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.

This arm will be the "control" condition; a Standard intervention with minimal contact.

Outcomes

Primary Outcome Measures

Markers of prediabetes
glucose tolerance and fasting glucose concentration
Muscular Strength
3 RM (repetition maximum - the maximum amount of weight that can be lifted three times)

Secondary Outcome Measures

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

Full Information

First Posted
April 22, 2010
Last Updated
March 19, 2014
Sponsor
Virginia Polytechnic Institute and State University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT01112709
Brief Title
Maintaining Resistance Training in Older Prediabetic Adults
Official Title
Maintaining Resistance Training in Older Prediabetic Adults: Theoretical Approach
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Virginia Polytechnic Institute and State University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Prediabetes
Keywords
Diabetes, Prediabetes, Resistance training, behavior, behavioral change theory

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
170 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SCT
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
This arm will be the "control" condition; a Standard intervention with minimal contact.
Intervention Type
Behavioral
Intervention Name(s)
SCT-based Resistance Training exercise program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Intervention with minimal contact
Intervention Description
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.
Primary Outcome Measure Information:
Title
Markers of prediabetes
Description
glucose tolerance and fasting glucose concentration
Time Frame
15 months
Title
Muscular Strength
Description
3 RM (repetition maximum - the maximum amount of weight that can be lifted three times)
Time Frame
15 months
Secondary Outcome Measure Information:
Title
Insulin secretion and action
Time Frame
15 Months
Title
Adherence to the resistance training program session schedule (twice/week sessions)
Time Frame
15 Months
Title
Social Cognitive Theory Measures (includes self-efficacy, self-regulation, outcome expectancies, and affect; related to resistance training)
Time Frame
15 Months
Title
Body Composition
Time Frame
15 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brenda M Davy, PhD, RD
Organizational Affiliation
Virginia Polytechnic Institute and State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard A Winett, PhD
Organizational Affiliation
Virginia Polytechnic Institute and State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Tech
City
Blacksburg
State/Province
Virginia
ZIP/Postal Code
24061
Country
United States
Facility Name
VT Riverside
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28231265
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.
Results Reference
derived
PubMed Identifier
26840904
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.
Results Reference
derived
PubMed Identifier
25064285
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.
Results Reference
derived

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Maintaining Resistance Training in Older Prediabetic Adults

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