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Provision of Breakfast Food in Behavioral Weight Loss

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT00200239
First received: September 12, 2005
Last updated: April 19, 2012
Last verified: December 2007
History of Changes
  Purpose

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.


Condition Intervention
Obesity
 Behavioral: Eating breakfast with portion and unportioned foods

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Provision of Breakfast Food in Behavioral Weight Loss

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Miriam Hospital:

Primary Outcome Measures:
  • Intake of breakfast foods [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Weight loss [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: September 2005
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Behavioral: eating breakfast from portioned and unportioned foods
 Behavioral: Eating breakfast with portion and unportioned foods
Behavioral: eating breakfast with portion and unportioned foods
Experimental: 2
Behavioral: eating breakfast with portioned and unportioned foods
 Behavioral: Eating breakfast with portion and unportioned foods
Behavioral: eating breakfast with portion and unportioned foods

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00200239

Locations
United States, Rhode Island
The Weight Control and Diabetes Research Center
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
The Miriam Hospital
Investigators
Principal Investigator: Hollie A Raynor, PhD University of Tennessee
  More Information

No publications provided

Responsible Party: The Miriam Hospital
ClinicalTrials.gov Identifier: NCT00200239     History of Changes
Other Study ID Numbers: 2047-05
Study First Received: September 12, 2005
Last Updated: April 19, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on May 19, 2013