Portion Control Treatment for Obesity
Portion Control for the Treatment of Obesity in the Primary Care Setting
1 other identifier
interventional
65
1 country
1
Brief Summary
To date, no studies have been published assessing the effectiveness of portion control interventions in a primary care setting. The investigators will conduct a pilot study to assess the effectiveness of an intervention including a portion control plate and dietary counseling for weight loss among obese patients in a general medicine primary care practice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 obesity
Started Jan 2009
Typical duration for phase_2 obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 11, 2011
CompletedFirst Posted
Study publicly available on registry
October 13, 2011
CompletedResults Posted
Study results publicly available
November 28, 2011
CompletedNovember 28, 2011
October 1, 2011
1.4 years
October 11, 2011
October 19, 2011
October 19, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight Change at 6 Months
Weight change as a percentage of baseline at post 6 months.
6 months
Secondary Outcomes (1)
Weight Change at 3 Months
3 months
Study Arms (2)
Portion Control Intervention
ACTIVE COMPARATORIndividuals will be given a portion control plate and dietary counseling
Usual Care
PLACEBO COMPARATORProvided with self-help booklets on diet and exercise.
Interventions
Individuals are provided with a portion control plate to use while eating and dietary counseling by dietician
self-help booklets
Eligibility Criteria
You may qualify if:
- Body Mass Index greater than 29 or less than 40
- Age between 18 and 75
You may not qualify if:
- Presence of active cancer
- Current participation in an organized weight loss program
- Current use of a weight loss medication
- History of bulimia or anorexia
- Current treatment for psychiatric illness other than anxiety or depression
- Surgery within the 3 months before enrollment or planned during the study period
- Past gastric bypass surgery or planned gastric bypass surgery during the - study period
- Current pregnancy or planned pregnancy during the study period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Related Publications (1)
Kesman RL, Ebbert JO, Harris KI, Schroeder DR. Portion control for the treatment of obesity in the primary care setting. BMC Res Notes. 2011 Sep 9;4:346. doi: 10.1186/1756-0500-4-346.
PMID: 21906302RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
small sample size and inability to blind staff/study subject to the intervenion
Results Point of Contact
- Title
- Jon O. Ebbert, MD
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Jon O Ebbert, MD
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 11, 2011
First Posted
October 13, 2011
Study Start
January 1, 2009
Primary Completion
June 1, 2010
Study Completion
December 1, 2010
Last Updated
November 28, 2011
Results First Posted
November 28, 2011
Record last verified: 2011-10