NCT01096719

Brief Summary

The purpose of this investigation is to conduct a 12-week pilot study to examine the effect of three different dietary prescriptions that differ on targeting reducing energy density (kcal/gram) and energy (kcal) on overall dietary intake, hunger, feelings of deprivation, satisfaction with the diet, mood, and weight loss in 45 overweight/obese adults receiving a 12-week behavioral weight loss intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jan 2010

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 31, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

April 5, 2018

Status Verified

April 1, 2018

Enrollment Period

6 months

First QC Date

March 24, 2010

Last Update Submit

April 3, 2018

Conditions

Obesity

Keywords

WeightDietary intakeEnergy DensityBehavioralSatietyDeprivationHungerFruitVegetable

Outcome Measures

Primary Outcomes (1)

  • Energy density of the diet

    Energy density is defined as the kilocalories per gram of a food. Energy density will be measured by collecting and analyzing 3-day food records using Nutrition Data Systems for Research at baseline (week 0) and post intervention (week 13).

    Weeks 0 and 13

Secondary Outcomes (3)

  • Weight Loss

    Weeks 0 and 13

  • Feelings of dietary deprivation and satisfaction

    Weeks 0 and 13

  • Hunger

    Weeks 0 and 13

Study Arms (3)

Energy Density

EXPERIMENTAL
Behavioral: Standard Behavioral Weight Loss InterventionBehavioral: Dietary Goal: Reduction in Energy Density of Dietary Intake

Lifestyle Treatment

ACTIVE COMPARATOR
Behavioral: Standard Behavioral Weight Loss InterventionBehavioral: Dietary Goal: Reduction of Energy Intake

Energy Density + Lifestyle Treatment

EXPERIMENTAL
Behavioral: Standard Behavioral Weight Loss InterventionBehavioral: Dietary Goal: Reduction in Energy Density of Dietary IntakeBehavioral: Dietary Goal: Reduction of Energy Intake

Interventions

Standard Behavioral Weight Loss InterventionBEHAVIORAL

12 week standard behavioral weight loss intervention including a physical activity goal and behavioral weight control strategies

Energy DensityEnergy Density + Lifestyle TreatmentLifestyle Treatment
Dietary Goal: Reduction in Energy Density of Dietary IntakeBEHAVIORAL

Consume low ED foods (ED \< 1.0) for at least 10 items consumed per day and limit high ED foods (ED \> 3.0) to two items consumed per day.

Energy DensityEnergy Density + Lifestyle Treatment
Dietary Goal: Reduction of Energy IntakeBEHAVIORAL

Limit energy intake to 1200 to 1500 kcals/day and \< 30% kcals from fat.

Energy Density + Lifestyle TreatmentLifestyle Treatment

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 21 and 65 years
  • Body mass index (BMI) between 25 and 45 kg/m2

You may not qualify if:

  • Report a health condition on the Physical Activity Readiness Questionnaire (PAR-Q)
  • Report being unable to walk for 2 blocks (1/4 mile) without stopping
  • Report major psychiatric diseases/organic brain syndromes via a phone screen
  • Are currently participating in a weight loss program and/or taking weight loss medication or lost \> 5% of body weight during the past 6 months
  • Intend to move to another city within the time frame of the investigation
  • Are pregnant, lactating, less than 6 months post-partum, or plan to become pregnant during the time frame of the investigation
  • Have had gastric surgery for weight loss

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Healthy Eating and Activity Laboratory

Knoxville, Tennessee, 37996-1920, United States

Location

Related Publications (1)

  • Raynor HA, Steeves EA, Hecht J, Fava JL, Wing RR. Limiting variety in non-nutrient-dense, energy-dense foods during a lifestyle intervention: a randomized controlled trial. Am J Clin Nutr. 2012 Jun;95(6):1305-14. doi: 10.3945/ajcn.111.031153. Epub 2012 May 2.

    PMID: 22552025DERIVED

Related Links

MeSH Terms

Conditions

ObesityBody WeightBehavior

Condition Hierarchy (Ancestors)

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

Study Officials

  • Hollie A Raynor, PhD, RD, LDN

    University of Tennessee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 24, 2010

First Posted

March 31, 2010

Study Start

January 1, 2010

Primary Completion

July 1, 2010

Study Completion

August 1, 2011

Last Updated

April 5, 2018

Record last verified: 2018-04

Locations

US(1)