Lifestyle Modification for Type 2 Diabetes Prevention in Overweight Youth

Obesity Clinical Trial

Official title:

Lifestyle Modification for Type 2 Diabetes Prevention in Overweight Youth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01610219
• Other study ID #: 807106
• Status: Completed
• Phase: N/A
• First received: May 30, 2012
• Last updated: May 31, 2012
• Start date: August 2008
• Est. completion date: January 2011

Study information

• Verified date: May 2012
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 8 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Obesity

Intervention

Behavioral:
• Lifestyle Modification for Type 2 Diabetes Prevention
Family based behavioral intervention utilizing Traffic Light Diet, self monitoring, goal setting, reinforcement and a tool kit containing physical activity-promoting items

Other:
• Nutrition and Physical Activity
This family based education program provided information on physical activity and healthy eating for parents and children.

Locations

Country	Name	City	State
United States	University of Pennsylvania Center for Weight and Eating Disorders/Perelman School of Medicine	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	American Diabetes Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Mass Index (BMI)	Change in BMI will be measured from baseline to end of intervention (6 months) and and also from 6 months to 12 months.	Baseline, 6 and 12 months	No
Primary	BMI-z score	Change in BMI-z score will be measured from baseline to end of treatment (6 months) and from 6 months to 12 months.	Baseline, 6 and 12 months	No
Primary	Percent overweight (% overweight)	Change in percent overweight will be measured from baseline to end of treatment (6 months) and from 6 months to 12 months. Percent overweight is computed as a child's actual BMI minus the median BMI for a child of comparable sex and age, divided by 100.	Baseline, 6 and 12 months	No
Primary	Waist Circumference(cm)	Change in waist circumference (cm) will be measured from baseline to end of treatment (6 months) and from end of treatment to 12 months.	Baseline, 6 and 12 months	No
Primary	Systolic Blood Pressure	Change in systolic blood pressure (mm Hg) will be measured from baseline to end of treatment (6 months) and from end of treatment to 12 months.	Baseline, 6 and 12 months	No
Primary	Diastolic Blood Pressure (mm Hg)	Change in diastolic blood pressure (mm Hg) will be measured from baseline to end of treatment (6 months) and from end of treatment to 12 months.	Baseline, 6 and 12 months	No
Primary	Pulse	Change in resting pulse will be measured from baseline to end of treatment (6 months) and from end of treatment to 12 months.	Baseline, 6 and 12 months	No
Primary	Physical Activity	Change in physical activity was measured from baseline to end of treatment (6 months) and from end of treatment to 12 months using an accelerometer. The accelerometer measured light, moderate and moderate-to-vigorous actity over 7 days.	Baseline, 6 and 12 months	No
Primary	Glucose	Change in blood glucose levels were measured at baseline, 6 and 12 months.	Baseline, 6 and 12 months	No
Primary	Insulin	Change in plasma insulin levels from baseline to end of treatment (6 months) and from 6 months to 12 months.	Baseline, 6 and 12 months	No
Primary	Change in HDL, LDL, Total Cholesterol and Triglycerides	Change in lipid profile measures from baseline to end of treatment (6 months) and from 6 months to 12 months.	Baseline, 6 and 12 months	No
Primary	Change in Dietary Intake	Change in energy (kcals/day), protein, carbohydrate, fat, cholesterol, saturated fat and fiber intake.	Baseline, 6 and 12 months	No
Secondary	Change in Parent BMI	Change in parent BMI from baseline to end of treatment (6 months) and from 6 motnths to 12 months.	Baseline, 6 and 12 months	Yes