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DiabetesPhase 2NCT01112709

Maintaining Resistance Training in Older Prediabetic Adults

A Phase 2 study testing SCT-based Resistance Training exercise program and Standard Intervention with minimal contact in people with Diabetes and Prediabetes, run by Virginia Polytechnic Institute and State University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 50 to 69 years
Conditions the study is for
Diabetes, Prediabetes
What is being tested?
SCT-based Resistance Training exercise program and Standard Intervention with minimal contact
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
2 sitesUnited States
Study dates
Jan 2011to Mar 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Virginia Tech

    Blacksburg, Virginia, 24061

  • VT Riverside

    Roanoke, Virginia, 24016

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
SCT-based Resistance Training exercise program, Standard Intervention with minimal contact
Keywords
Diabetes, Prediabetes, Resistance training, behavior, behavioral change theory
Medical subject headings
Diabetes Mellitus, Prediabetic State, Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SCT-based Resistance Training exercise programBehavioural

    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.

  • 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.

Study groups in NCT01112709
Study groupRoleWhat they receive
SCTExperimentalThis arm is a long-term, Social Cognitive Theory (SCT)-based intervention, emphasizing self-regulation and other SCT strategies to optimize training, with faded contact.
Receives: Behavioral: SCT-based Resistance Training exercise program
ControlActive comparatorThis arm will be the "control" condition; a Standard intervention with minimal contact.
Receives: Other: Standard Intervention with minimal contact

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Markers of prediabetes

    glucose tolerance and fasting glucose concentration

    Measured: 15 months

  2. Muscular Strength

    3 RM (repetition maximum - the maximum amount of weight that can be lifted three times)

    Measured: 15 months

Secondary outcomes (4)

  1. Insulin secretion and action

    Measured: 15 Months

  2. Adherence to the resistance training program session schedule (twice/week sessions)

    Measured: 15 Months

  3. Social Cognitive Theory Measures (includes self-efficacy, self-regulation, outcome expectancies, and affect; related to resistance training)

    Measured: 15 Months

  4. Body Composition

    Measured: 15 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2010 (estimated)
  2. Study startJan 2011
  3. Primary completionMar 2014
  4. Study completionMar 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01112709
Sponsor's protocol ID
1R01DK082383-01A1
Other IDs
R01DK082383
Status last verified
Mar 2014
First submitted
22 Apr 2010
Last updated
20 Mar 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 28231265

  • 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.

    PubMed 26840904

  • 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.

    PubMed 25064285

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SCT-based Resistance Training exercise program and Standard Intervention with minimal contact in people with Diabetes and Prediabetes, run by Virginia Polytechnic Institute and State University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Markers of prediabetes (time frame: 15 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01112709, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2014.

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