Status:
COMPLETED
Reducing Snack Variety in Weight Loss Treatment
Lead Sponsor:
The Miriam Hospital
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Obesity
Eligibility:
All Genders
21-65 years
Phase:
NA
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 d...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT00328744
Start Date
July 1 2006
End Date
October 1 2010
Last Update
April 20 2012
Active Locations (1)
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1
The Miriam Hospital
Providence, Rhode Island, United States, 02903