Provision of Breakfast Food in Behavioral Weight Loss

NCT ID: NCT00200239

Last Updated: 2012-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2006-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Behavioral: eating breakfast from portioned and unportioned foods

Group Type EXPERIMENTAL

Eating breakfast with portion and unportioned foods

Intervention Type BEHAVIORAL

Behavioral: eating breakfast with portion and unportioned foods

2

Behavioral: eating breakfast with portioned and unportioned foods

Group Type EXPERIMENTAL

Eating breakfast with portion and unportioned foods

Intervention Type BEHAVIORAL

Behavioral: eating breakfast with portion and unportioned foods

Interventions

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Eating breakfast with portion and unportioned foods

Behavioral: eating breakfast with portion and unportioned foods

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Age between 21 and 65 years. Older adults may have more medical co-morbidities and may require greater medical supervision.
2. 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.
3. Average current consumption of breakfast on four days or fewer.

Exclusion Criteria

1. 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.
2. 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.
3. Report major psychiatric diseases or organic brain syndromes.
4. 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.
5. 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.
6. Are pregnant, lactating, less than 6 months post-partum, or plan to become pregnant during the time frame of the investigation.
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Miriam Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hollie A Raynor, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Tennessee

Locations

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The Weight Control and Diabetes Research Center

Providence, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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2047-05

Identifier Type: -

Identifier Source: org_study_id

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