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Provision of Breakfast Food in Behavioral Weight Loss

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Eating breakfast with portion and unportioned foods
Sponsored by
The Miriam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

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 and may require greater medical supervision. Body mass index (BMI) between 25 and 40 kg/m2. Based upon the Evidence Report (National Heart, Lung, and Blood Institute [NHLBI], 1998), weight loss is recommended for individuals with a BMI > 25. However, individuals with a BMI of > 40 have more medical co-morbidities and require greater medical supervision. Average current consumption of breakfast on four days or fewer. Exclusion Criteria: Report allergies to any of the foods provided in the treatment or report lactose intolerance due to the high lactose content of some of the foods provided. Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q) (Thomas, Reading, & Shephard, 1992). 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. 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 to another city within the time frame of the investigation or will be out of town and unavailable for meetings for more than one week during the treatment program. Are pregnant, lactating, less than 6 months post-partum, or plan to become pregnant during the time frame of the investigation.

Sites / Locations

  • The Weight Control and Diabetes Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Behavioral: eating breakfast from portioned and unportioned foods

Behavioral: eating breakfast with portioned and unportioned foods

Outcomes

Primary Outcome Measures

Intake of breakfast foods

Secondary Outcome Measures

Weight loss

Full Information

First Posted
September 12, 2005
Last Updated
April 19, 2012
Sponsor
The Miriam Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00200239
Brief Title
Provision of Breakfast Food in Behavioral Weight Loss
Official Title
Provision of Breakfast Food in Behavioral Weight Loss
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Miriam Hospital

4. Oversight

5. Study Description

Brief Summary
A contributing factor to the rising prevalence of obesity may be increased portion sizes. However, the effect of portion size has not been studied independent of the effect of quantity of food in the context of a behavioral weight loss program. Providing pre-portioned single servings of food may make it easier to reduce caloric and dietary fat intake improving weight loss. In addition, breakfast skipping is associated with obesity and breakfast consumption is associated with weight loss success. Therefore, the objective of the proposed study is to investigate the effect of portion size on consumption of provided breakfast foods in the context of a behavioral weight loss program. Participants will be randomized to 1 of 2 standard 12-week behavioral obesity interventions. The first intervention, serving as a control, will provide participants with breakfast foods in non-portioned containers (Standard). A second intervention will provide participants with the same type and quantity of breakfast foods but they will be provided in pre-portioned single servings (Portion). Dependent variables include the number of calories consumed from the provided foods as well as overall caloric and fat consumption. If the provision of food in pre-portioned servings is effective at decreasing intake, future directions include conducting longer interventions to improve long-term weight loss outcomes in standard behavioral interventions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Behavioral: eating breakfast from portioned and unportioned foods
Arm Title
2
Arm Type
Experimental
Arm Description
Behavioral: eating breakfast with portioned and unportioned foods
Intervention Type
Behavioral
Intervention Name(s)
Eating breakfast with portion and unportioned foods
Intervention Description
Behavioral: eating breakfast with portion and unportioned foods
Primary Outcome Measure Information:
Title
Intake of breakfast foods
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Weight loss
Time Frame
8 weeks

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 and may require greater medical supervision. Body mass index (BMI) between 25 and 40 kg/m2. Based upon the Evidence Report (National Heart, Lung, and Blood Institute [NHLBI], 1998), weight loss is recommended for individuals with a BMI > 25. However, individuals with a BMI of > 40 have more medical co-morbidities and require greater medical supervision. Average current consumption of breakfast on four days or fewer. Exclusion Criteria: Report allergies to any of the foods provided in the treatment or report lactose intolerance due to the high lactose content of some of the foods provided. Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q) (Thomas, Reading, & Shephard, 1992). 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. 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 to another city within the time frame of the investigation or will be out of town and unavailable for meetings for more than one week during the treatment program. Are pregnant, lactating, less than 6 months post-partum, or plan to become pregnant during the time frame of the investigation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hollie A Raynor, PhD
Organizational Affiliation
University of Tennessee
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Weight Control and Diabetes Research Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

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Provision of Breakfast Food in Behavioral Weight Loss

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