NCT02079831

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 6, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

January 11, 2016

Status Verified

January 1, 2016

Enrollment Period

1.3 years

First QC Date

March 3, 2014

Last Update Submit

January 7, 2016

Conditions

Pediatric Obesity

Keywords

Adolescent obesitychildhood obesityanthropometrybody weights and measures

Outcome Measures

Primary Outcomes (1)

  • BMI Z-Score

    up to Week 12

Secondary Outcomes (2)

  • Subjective Ratings of Appetite

    Baseline and Week 12

  • Hexosamine Biosynthetic Pathway

    Baseline and Week 12

Other Outcomes (5)

  • Glucose

    Baseline and Week 12

  • Insulin

    Baseline and Week 12

  • Cholesterol

    Baseline and Week 12

  • +2 more other outcomes

Study Arms (2)

Higher protein and energy restriction

EXPERIMENTAL

Participants in this arm will consume 30% of energy as protein with 25% energy restriction.

Behavioral: Energy RestrictionBehavioral: Higher protein

Lower protein and energy restriction

EXPERIMENTAL

Participants in this arm will consume 15% of energy as protein with 25% energy restriction.

Behavioral: Energy RestrictionBehavioral: Lower Protein

Interventions

Energy RestrictionBEHAVIORAL

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.

Higher protein and energy restrictionLower protein and energy restriction
Higher proteinBEHAVIORAL

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.

Higher protein and energy restriction
Lower ProteinBEHAVIORAL

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.

Lower protein and energy restriction

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Medications:
  • Diuretics
  • Beta-blocker
  • Weight loss medications, diet pills
  • Anti-inflammatory drugs (corticosteroid/anabolic steroid/NSAID)
  • Antipsychotic medications
  • Other medications that may affect fluid balance or weight
  • Lifestyle:
  • Plans to move out of the study area within the next 4 months, or plan to be out of the study area for more than 3 weeks during the course of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Pediatric ObesityBody Weight

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • John W Apolzan, PhD

    Pennington Biomedical

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 3, 2014

First Posted

March 6, 2014

Study Start

March 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

January 11, 2016

Record last verified: 2016-01

Locations

US(1)