Lifestyle Modification for Type 2 Diabetes Prevention in Overweight Youth

NCT01610219 | Completed

• 1 other identifier: 807106
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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. 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. 2.Greater reductions in child excess body weight will be associated with greater improvements in metabolic and cardiovascular measures.
3. 3.Compared to parents receiving the NPA intervention, parents receiving the LMDP intervention will show greater reductions in BMI.
4. 4.Greater improvements in parent BMI will be associated with greater improvements in child body composition, metabolic and cardiovascular measures, and behavioral outcomes.
5. 5.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.

Conditions

Diabetes Mellitus, Type 2; Obesity

Outcome Measures

Primary Outcomes (12)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Glucose

  Change in blood glucose levels were measured at baseline, 6 and 12 months.

  Baseline, 6 and 12 months

• 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

• 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

• Change in Dietary Intake

  Change in energy (kcals/day), protein, carbohydrate, fat, cholesterol, saturated fat and fiber intake.

  Baseline, 6 and 12 months

Secondary Outcomes (1)

• Change in Parent BMI

  Baseline, 6 and 12 months

Study Arms (2)

Lifestyle Modification for Diabetes Prevention

ACTIVE COMPARATOR

Family based intervention utilizing Traffic Light Diet, self monitoring, parent behavioral skill training and tool kit of items promoting physical activity.

Behavioral: Lifestyle Modification for Type 2 Diabetes Prevention

Nutrition and Physical Activity

OTHER

Family based intervention providing education on healthy eating and physical activity but no behavioral skills training, goal setting, self monitoring or physical activity toolkit.

Other: Nutrition and Physical Activity

Interventions

Lifestyle Modification for Type 2 Diabetes Prevention BEHAVIORAL

Family based behavioral intervention utilizing Traffic Light Diet, self monitoring, goal setting, reinforcement and a tool kit containing physical activity-promoting items

Lifestyle Modification for Diabetes Prevention

Nutrition and Physical Activity OTHER

This family based education program provided information on physical activity and healthy eating for parents and children.

Nutrition and Physical Activity

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• American Diabetes Association: collaborator

Study Sites (1)

University of Pennsylvania Center for Weight and Eating Disorders/Perelman School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Interventions

Nutritional Status; Exercise

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Myles S Faith, Ph.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2012
• First Posted: June 1, 2012
• Study Start: August 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: June 1, 2012

Record last verified: 2012-05

Locations

US (1)