NCT00328744

Brief Summary

The rising prevalence of obesity in the United States is believed to be due to increased exposure to adverse environmental factors, such as food portion sizes and increased dietary variety. Although decreasing portion sizes is a strategy used in weight loss programs, research has not studied the effects of decreasing dietary variety. Cross-sectional studies show a positive association between variety and body weight and in our own studies the investigators have shown that greater reductions in the number of different snack foods (i.e., cookies, chips) consumed predicted greater decreases in overall caloric and fat intake and greater weight loss. Limiting variety may reduce intake through long-term sensory-specific satiety and/or monotony. Reducing dietary variety is a novel dietary approach with the potential to improve long-term weight loss, which has not been studied as a clinical strategy in obesity research. The objective of this application is to conduct a randomized controlled trial of a behavioral weight loss intervention limiting the number of different snack foods consumed. Two hundred overweight and obese participants will be randomized to a standard behavioral intervention (Standard) or to a standard behavioral intervention that also limits the number of different snack foods consumed (Limited Variety). Both conditions will receive an 18-month standard behavioral intervention, using behavioral techniques (i.e., self-monitoring) to change eating behaviors. Participants in the Limited Variety condition will also limit variety in snack foods to only two chosen snack foods throughout the intervention. Measures of weight, snack food consumption and hedonics, and diet satisfaction will be taken at 0, 6, 12, and 18 months. This investigation will determine:

  1. 1.if the Limited Variety condition produces greater weight loss than the Standard condition at 18 months;
  2. 2.if the Limited Variety condition consumes fewer servings and calories from snack foods than the Standard condition;
  3. 3.if limiting snack food variety produces long-term sensory-specific satiety and/or monotony.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
202

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jul 2006

Longer than P75 for not_applicable obesity

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

First Submitted

Initial submission to the registry

May 19, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 22, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

April 20, 2012

Status Verified

October 1, 2008

Enrollment Period

4.3 years

First QC Date

May 19, 2006

Last Update Submit

April 19, 2012

Conditions

Obesity

Keywords

WeightDietary intakeEnergyHedonicsBehavioralSensory-specific satietyMonotony

Outcome Measures

Primary Outcomes (1)

  • Weight loss

    18 months

Secondary Outcomes (2)

  • Diet

    18 months

  • Hedonics of food

    18 months

Study Arms (2)

1

EXPERIMENTAL

Behavioral: Behavioral weight loss (Standard)

Behavioral: Standard

2

EXPERIMENTAL

Behavioral: Behavioral weight loss (Limited Variety)

Behavioral: StandardBehavioral: Limited Variety

Interventions

StandardBEHAVIORAL

18-month standard behavioral weight loss intervention

12
Limited VarietyBEHAVIORAL

Two chosen snack foods

2

Eligibility Criteria

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

You may qualify if:

  • Age between 21 and 65 years. Older adults may have more medical co-morbidities, requiring greater medical supervision. Although pediatric obesity is a significant concern, this group has different nutritional needs and requires different levels of therapist and parental involvement than are proposed.
  • Body mass index (BMI) between 27 and 45 kg/m2. Based upon the Evidence Report (72), weight loss is recommended for individuals with a BMI \> 25. A BMI of \> 27 was chosen as eligibility criteria for this investigation because this level of BMI will allow for a 10% weight loss to occur prior to reaching a BMI of \< 25. Individuals with a BMI of \> 45 have more medical co-morbidities and require greater medical supervision, and thus will be considered ineligible for this investigation.

You may not qualify if:

  • Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q) (73). Individuals endorsing joint problems, prescription medication usage, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate.
  • Have an allergy to a food commonly found in snack foods (i.e., nuts, milk and egg proteins).
  • Report major psychiatric diseases or organic brain syndromes.
  • 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 outside of the metropolitan area 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.
  • Consume \< 5 different types of snack food per week. Pilot data indicated that upon screening 44 participants, mean weekly variety of snack foods was 8.7 (range 2 to 14, with only two participants consuming \< 5 snack foods per week).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (1)

  • Raynor HA, Van Walleghen EL, Bachman JL, Looney SM, Phelan S, Wing RR. Dietary energy density and successful weight loss maintenance. Eat Behav. 2011 Apr;12(2):119-25. doi: 10.1016/j.eatbeh.2011.01.008. Epub 2011 Jan 25.

    PMID: 21385641DERIVED

MeSH Terms

Conditions

ObesityBody WeightBehavior

Condition Hierarchy (Ancestors)

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

Study Officials

  • Hollie Raynor, PhD

    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
SPONSOR

Study Record Dates

First Submitted

May 19, 2006

First Posted

May 22, 2006

Study Start

July 1, 2006

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

April 20, 2012

Record last verified: 2008-10

Locations

US(1)