search
Back to results

Reducing Snack Variety in Weight Loss Treatment

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard
Limited Variety
Sponsored by
The Miriam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Weight, Dietary intake, Energy, Hedonics, Behavioral, Sensory-specific satiety, Monotony

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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).

Sites / Locations

  • The Miriam Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Behavioral: Behavioral weight loss (Standard)

Behavioral: Behavioral weight loss (Limited Variety)

Outcomes

Primary Outcome Measures

Weight loss

Secondary Outcome Measures

Diet
Hedonics of food

Full Information

First Posted
May 19, 2006
Last Updated
April 19, 2012
Sponsor
The Miriam Hospital
Collaborators
National Institutes of Health (NIH)
search

1. Study Identification

Unique Protocol Identification Number
NCT00328744
Brief Title
Reducing Snack Variety in Weight Loss Treatment
Official Title
Reducing Snack Food Variety During Obesity Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Miriam Hospital
Collaborators
National Institutes of Health (NIH)

4. Oversight

5. Study Description

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: if the Limited Variety condition produces greater weight loss than the Standard condition at 18 months; if the Limited Variety condition consumes fewer servings and calories from snack foods than the Standard condition; if limiting snack food variety produces long-term sensory-specific satiety and/or monotony. Relevance: Experimental studies show that limiting dietary variety profoundly reduces intake. To date, there is no dietary prescription that has been tested that capitalizes on the effect of variety on intake that can be maintained. This will be the first investigation to examine methods of manipulating dietary variety that can be adhered to over time and that influence intake, weight loss, and weight loss maintenance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Weight, Dietary intake, Energy, Hedonics, Behavioral, Sensory-specific satiety, Monotony

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Behavioral: Behavioral weight loss (Standard)
Arm Title
2
Arm Type
Experimental
Arm Description
Behavioral: Behavioral weight loss (Limited Variety)
Intervention Type
Behavioral
Intervention Name(s)
Standard
Intervention Description
18-month standard behavioral weight loss intervention
Intervention Type
Behavioral
Intervention Name(s)
Limited Variety
Intervention Description
Two chosen snack foods
Primary Outcome Measure Information:
Title
Weight loss
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Diet
Time Frame
18 months
Title
Hedonics of food
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hollie Raynor, PhD
Organizational Affiliation
University of Tennessee
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21385641
Citation
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.
Results Reference
derived

Learn more about this trial

Reducing Snack Variety in Weight Loss Treatment

We'll reach out to this number within 24 hrs