Clinical trial NCT01610219: Lifestyle Modification for Type 2 Diabetes Prevention in Overweight Youth
Official title: Lifestyle Modification for Type 2 Diabetes Prevention in Overweight Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Obesity
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
First posted: 2012-06-01
Enrollment: 52
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Age 4-8 years old
* Age- and sex-specific BMI ≥95th percentile

Exclusion Criteria:

* Children with serious medical conditions
* Children who show signs of elevated psychopathology, as assessed by the Child Behavior Checklist (CBCL)
* Children of parents with significantly elevated psychiatric disorders

Primary outcomes:
measure: Body Mass Index (BMI)
timeFrame: Baseline, 6 and 12 months
measure: BMI-z score
timeFrame: Baseline, 6 and 12 months
measure: Percent overweight (% overweight)
timeFrame: Baseline, 6 and 12 months
measure: Waist Circumference(cm)
timeFrame: Baseline, 6 and 12 months
measure: Systolic Blood Pressure
timeFrame: Baseline, 6 and 12 months
measure: Diastolic Blood Pressure (mm Hg)
timeFrame: Baseline, 6 and 12 months
measure: Pulse
timeFrame: Baseline, 6 and 12 months
measure: Physical Activity
timeFrame: Baseline, 6 and 12 months
measure: Glucose
timeFrame: Baseline, 6 and 12 months
measure: Insulin
timeFrame: Baseline, 6 and 12 months
measure: Change in HDL, LDL, Total Cholesterol and Triglycerides
timeFrame: Baseline, 6 and 12 months
measure: Change in Dietary Intake
timeFrame: Baseline, 6 and 12 months
Secondary outcomes:
measure: Change in Parent BMI
timeFrame: Baseline, 6 and 12 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Center for Weight and Eating Disorders/Perelman School of Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Myles S Faith, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: