Lifestyle Modification for Type 2 Diabetes Prevention in Overweight Youth
Condition: Diabetes Mellitus, Type 2; Obesity
MeSH terms: Diabetes Mellitus; Overweight; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The number of youth with Type 2 diabetes (T2D) is rising in the population, which is a
      concerning public health trend. There has been little research testing ways to prevent the
      development of this disease in children who are at increased risk to develop T2D. This study
      tests a family treatment program that treats 4-8 year old children who are at risk for T2D
      because they are overweight and have a family history of the disease. Sixty at risk children
      and their parents were assigned to one of 2 treatment conditions. Half of the families
      (randomly determined) received an intensive family treatment program that trains parents in
      how to increase healthier foods choices and physical activity for themselves and their
      children using "behavior modification" strategies. Children receiving this treatment were
      allowed to taste new fruits and vegetables used a pedometer to record how far they walked
      every day, and were given a "tool box" of toys and interactive games which promoted physical
      activity. The other half of the families only received instruction about healthier choices,
      but received no behavioral modification strategies or physical activity promotion tools.
      Improvements in children's body weight, blood measures, and behavior patterns were measured
      after treatment ended (6 months) and then again after 12 months. The results may lead to a
      better understanding of how family members can positively influence young children's
      behaviors to help prevent T2D. The objective of proposed study was to test a family-based
      intervention designed to reduce excess body weight, improve metabolic and cardiovascular
      profile, and improve diet and physical activity levels in 4 - 8 year old youth who are "at
      risk" for T2D. This intervention was tested in a 2-arm randomized controlled clinical trial.

      Primary Hypotheses:

        1. Compared to children receiving NPA, children receiving LMDP will show greater reductions
           in excess body weight, greater improvements in metabolic and cardiovascular measures,
           improved diet, increased physical activity, and reduced television viewing.

        2. Greater reductions in child excess body weight will be associated with greater
           improvements in metabolic and cardiovascular measures.

      Secondary Hypotheses:

        1. Compared to parents receiving the NPA intervention, parents receiving the LMDP
           intervention will show greater reductions in BMI.

        2. Greater improvements in parent BMI will be associated with greater improvements in child
           body composition, metabolic and cardiovascular measures, and behavioral outcomes.

        3. Compared to families receiving the NPA intervention, families receiving the LMDP
           intervention will show an increase in the number of fruits and vegetables and lower
           energy density foods stored at home.
    

Detailed description: 
      There is mounting concern about the development of Type 2 diabetes (T2D) in youth, especially
      in light of rising childhood obesity rates at younger ages. The health costs of T2D are
      notable both for the individual and society, and so interventions that can help prevent the
      development of T2D in early life are needed. Fortunately, there is promising evidence from
      the Diabetes Prevention Program (DPP) and other randomized trials with adults that the onset
      of T2D can be prevented through sustainable lifestyle changes. However, intervention programs
      have not been tested in young children who are "at risk" for developing the disease, even
      though this may be a critical period for obesity onset and for the formation of early eating
      and physical activity habits.

      The primary aim of the proposed study was to test a family-based intervention that targets
      improvements in excess weight gain, metabolic and cardiovascular profile, and diet and
      physical activity in 4 - 8 year old children who are "at risk" for T2D. Specifically, 60
      families were randomized either to one of two treatments: Lifestyle Modification for Diabetes
      Prevention (LMDP, N= 30) or Nutrition and Physical Activity Information (NPA, N= 30). The
      LMDP intervention trained families in behavioral strategies to increase parent and child
      intake of fruits, vegetables, and high fiber foods, to limit intake of energy-dense foods,
      and to increase daily physical activity. A physical activity "tool kit" for the home
      environment was provided to families. Supporting information about T2D and obesity, as well
      as nutrition and physical activity, also were provided. Besides the participating
      parent-child pair, other adult family members with T2D (eg, grandparents, aunts, uncles) were
      encouraged to participate. The LMDP activities were intended to reduce children's excess body
      weight and improve their metabolic and cardiovascular measures, to help prevent the onset of
      insulin resistance. The NPA intervention only received basic information on T2D and obesity,
      and nutrition and physical activity recommendations. Changes in child body composition,
      metabolic and cardiovascular measures, and behavioral outcomes were evaluated at 6 months
      (ie, end-of-treatment) and 12 months (ie, follow up). Changes in parent weight status and the
      home food environment were secondary outcomes and were assessed as potential mediators of
      child outcomes.
    

Intervention name(s): Lifestyle Modification for Type 2 Diabetes Prevention; Nutrition and Physical Activity
Intervention type(s): Behavioral; Other
Intervention description(s): Family based behavioral intervention utilizing Traffic Light Diet, self monitoring, goal setting, reinforcement and a tool kit containing physical activity-promoting items; This family based education program provided information on physical activity and healthy eating for parents and children.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment