Pediatric Obesity
Conditions
Keywords
Adolescent obesity, childhood obesity, anthropometry, body weights and measures
Brief summary
The aim of the proposed study is to provide important data on weight loss efficacy in overweight and obese adolescents on an isocaloric higher protein diet vs a lower protein diet utilizing the U.S. Department of Agriculture (USDA) MyPlate nutrition guide. The investigators hypothesize that the higher protein diet will result in greater weight loss due to increased satiety and better dietary adherence.
Detailed description
Aim 1 is to test the efficacy of a personalized higher protein weight loss intervention compared to a lower protein intervention which use the USDA MyPlate nutrition guide. It is hypothesized that participants randomly assigned to the higher protein dietary treatment will lose more weight based on BMI-Z score over 12 weeks compared to participants in the lower dietary protein treatment. Aim 2 is to test if changes in subjective ratings of appetite differ by dietary treatment (i.e. protein intake). It is hypothesized that participants in the higher protein intervention will report a decrease in hunger and an increase in fullness compared to participants in the lower protein intervention. Aim 3 is to test if change in the hexosamine biosynthetic pathway (HBP) measured at the rate limiting step of glutamine fructose-6-phosphate amidotransferase (GFAT) and glycosylation measured as O-linked N-acetylglucosamine (GlcNAc) transferase (OGT) differ by dietary treatment. It is hypothesized that participants randomly assigned to the higher protein dietary treatment will have decreased change from baseline levels of GFAT and glycosylation (OGT) due to decreased carbohydrate intake compared to the lower protein treatment. Exploratory Aims: As exploratory aims, the investigators will test if the higher protein or lower protein dietary treatments differentially alter glucose, insulin, cholesterol, and triglycerides (markers of the metabolic syndrome).
Interventions
BEHAVIORALEnergy Restriction
Participants will receive an intervention specifically designed for adolescents and their group assignment that relies on nutrition education, nutritional counseling, social cognitive therapy, behavioral strategies, self-monitoring, portion size reduction, and increased physical activity. Participants will get an individualized dietary meal plan. Dietary counseling will be based on the MyPlate guidelines with extra attention and focus on appropriate protein food choice. Also in accordance to the MyPlate guidelines, all participants will be instructed to increase physical activity to 60 minutes a day as aerobic physical activity.
BEHAVIORALHigher protein
The higher protein group will be instructed to consume 30% of energy as protein, with 25% and 45% of energy from fat and carbohydrate, respectively.
BEHAVIORALLower Protein
The lower protein group will be instructed to consume 15% of energy as protein, with 25% and 60% of energy from fat and carbohydrate, respectively.
Sponsors
Pennington Biomedical Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Be male or female * Be between the ages of 12 and 17, inclusive * Be at or above the 85th BMI percentile (a number calculated from the participants height, weight, sex, and date of birth) * Be willing to fast for 12 hours prior to clinic study visits 2 and 4 * Be willing to participate in the research study
Exclusion criteria
* Health Conditions: * Has HIV or AIDS * Has uncontrolled CVD or arrhythmia * Has Type I or Type II diabetes. * Is unable or unwilling to complete the study procedures * Participant may not qualify for this study based on other
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BMI Z-Score | up to Week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Ratings of Appetite | Baseline and Week 12 | — |
| Hexosamine Biosynthetic Pathway | Baseline and Week 12 | glutamine fructose-6-phosphate amidotransferase (GFAT) and glycosylation measured as O-linked N-acetylglucosamine (GlcNAc) transferase (OGT) measurement |
Other
| Measure | Time frame |
|---|---|
| Triglycerides | Baseline and Week 12 |
| Glucose | Baseline and Week 12 |
| Blood Pressure | Baseline and Week 12 |
| Insulin | Baseline and Week 12 |
| Cholesterol | Baseline and Week 12 |
Countries
United States
Outcome results
None listed