NCT01112709

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for phase_2 diabetes

Timeline
Completed

Started Jan 2011

Typical duration for phase_2 diabetes

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 28, 2010

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

March 20, 2014

Status Verified

March 1, 2014

Enrollment Period

3.2 years

First QC Date

April 22, 2010

Last Update Submit

March 19, 2014

Conditions

DiabetesPrediabetes

Keywords

DiabetesPrediabetesResistance trainingbehaviorbehavioral change theory

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • 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

Study Arms (2)

SCT

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Other: Standard Intervention with minimal contact

Interventions

SCT-based Resistance Training exercise programBEHAVIORAL

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.

SCT
Standard Intervention with minimal contactOTHER

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.

Control

Eligibility Criteria

Age50 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Virginia Tech

Blacksburg, Virginia, 24061, United States

Location

VT Riverside

Roanoke, Virginia, 24016, United States

Location

Related Publications (3)

  • 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.

    PMID: 28231265DERIVED

  • 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.

    PMID: 26840904DERIVED

  • 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.

    PMID: 25064285DERIVED

MeSH Terms

Conditions

Diabetes MellitusPrediabetic StateBehavior

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Brenda M Davy, PhD, RD

    Virginia Polytechnic Institute and State University

    PRINCIPAL INVESTIGATOR

  • Richard A Winett, PhD

    Virginia Polytechnic Institute and State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 22, 2010

First Posted

April 28, 2010

Study Start

January 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

March 20, 2014

Record last verified: 2014-03

Locations

US(2)