Maintaining Resistance Training in Older Prediabetic Adults
Condition: Diabetes; Prediabetes
MeSH terms: Prediabetic State; Glucose Intolerance
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): SCT-based Resistance Training exercise program; Standard Intervention with minimal contact
Intervention type(s): Behavioral; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Diabetes; Prediabetes; Resistance training; behavior; behavioral change theory