Phase 3 N=65 Randomized Treatment

Portion Control Treatment for Obesity

Obesity

Bottom Line

View on ClinicalTrials.gov: NCT01451554 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2011

Primary outcome: Primary: Weight Change at 6 Months — -1.2; -0.4 percentage — p=0.31

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: portion control plate (Behavioral); Usual Care (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Mayo Clinic
Primary completion: Jun 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Weight Change at 6 Months	-1.2; -0.4	0.31
SECONDARY Weight Change at 3 Months	-1.7; -0.4	0.06

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.

Eligibility Criteria

Inclusion Criteria

Body Mass Index greater than 29 or less than 40
Age between 18 and 75

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01451554). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.