Portion Control Treatment for Obesity

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT01451554
• Collaborator: (none)
• Enrollment: 65
• Location: 1
• Arms: 2
• Duration (Months): 23
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Behavioral: portion control plate; Behavioral: Usual Care	Phase 2/Phase 3

Detailed Description

2-3 weeks prior to the patient's appointment with their primary care physician, the patient's medical record is reviewed to assess eligibility. If eligible, baseline patient characteristics are recorded, and a letter is sent to the patient informing them of the study and asking them to discuss this further with their primary care provider at their upcoming appointment.

At the primary care appointment, the patient is informed of the study and asked if they would like to participate. If the patient declines, their response is recorded. If the patient accepts, authorization is obtained and the patient is randomized by drawing a sealed envelope from either the male box or the female box, with both boxes being randomized. The envelope indicates either portion control plate or usual care. If the patient is randomized to usual care, Mayo Clinic pamphlets entitled "Lifestyle Changes for Healthy Weight" and "Exercise: Getting Started and Staying With It" are given to the patient. If the patient is randomized to the portion control plate, a 60 minute appointment with a dietician is scheduled. For pre-menopausal female patients who have not had a hysterectomy, a urine pregnancy test is performed to confirm that the patient is not pregnant prior to participation in the study.

At the dietitian appointment, the patient is given general information regarding portion size control and specific instructions on how to use a commercially calibrated portion control plate/bowl. The patient receives a handout containing instructions on how to use the plate/bowl along with food suggestions. The patient is instructed to use the plate for their largest meal of the day and encouraged to use the plate/bowl for all meals. The patient is also given a simple log-sheet to document the meals each day for which they used the plate/bowl.

The patients are then followed for 6 months. All patients are scheduled for weigh-ins at 3 months and 6 months. Patients in the portion control plate group are also contacted by phone or email (according to patient preference) at 1, 3, and 5 months by the dietitian to check-in and answer all questions. At completion of the study, patients in the portion control group are provided with a survey to assess their satisfaction with the intervention.

Study Design

• Study Type: Interventional
• Actual Enrollment: 65 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Portion Control for the Treatment of Obesity in the Primary Care Setting
• Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Jun 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Portion Control Intervention Individuals will be given a portion control plate and dietary counseling	Behavioral: portion control plate; Individuals are provided with a portion control plate to use while eating and dietary counseling by dietician; Other Names: dietary counseling weight loss intervention
Placebo Comparator: Usual Care Provided with self-help booklets on diet and exercise.	Behavioral: Usual Care; self-help booklets; Other Names: self-help booklets(exercise and lifestyle changes)

Outcome Measures

Primary Outcome Measures

1. Weight Change at 6 Months [6 months]

   Weight change as a percentage of baseline at post 6 months.

Secondary Outcome Measures

1. Weight Change at 3 Months [3 months]

   Percentage change in weight at 3 months post study baseline

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Jon O Ebbert, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jon Ebbert, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT01451554
• Other Study ID Numbers: 02-003653
• First Posted: Oct 13, 2011
• Last Update Posted: Nov 28, 2011
• Last Verified: Oct 1, 2011

• Keywords provided by Jon Ebbert, Principal Investigator, Mayo Clinic: weight; body mass index; obesity; portion control plate; diet; exercise
• Additional relevant MeSH terms: Obesity

Study Results

Participant Flow

Recruitment Details	Patients were referred to the study by their primary health care provider. Recruitment began on January 14, 2009 and ended on May 21, 2010.

Arm/Group Title	Portion Control Intervention	Usual Care
Arm/Group Description	Individuals will be given a portion control plate and dietary counseling	Provided with self-help booklets on diet and exercise.
Period Title: Overall Study
STARTED	33	32
COMPLETED	19	23
NOT COMPLETED	14	9

Baseline Characteristics

Arm/Group Title	Portion Control Intervention	Usual Care	Total
Arm/Group Description	Individuals will be given a portion control plate and dietary counseling	Provided with self-help booklets on diet and exercise.	Total of all reporting groups
Overall Participants	33	32	65
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	28 84.8%	24 75%	52 80%
>=65 years	5 15.2%	8 25%	13 20%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.4 (9.4)	56.3 (10.7)	55.9 (10.0)
Sex: Female, Male (Count of Participants)
Female	20 60.6%	20 62.5%	40 61.5%
Male	13 39.4%	12 37.5%	25 38.5%
Baseline Weight (Kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kg]	97.6 (12.8)	98.8 (12.5)	98.2 (12.6)

Outcome Measures

1. Secondary Outcome

Title	Weight Change at 3 Months
Description	Percentage change in weight at 3 months post study baseline
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Intent to treat population includes all randomzied subjects. Missing data were imputed using the last observation carried forward.

Arm/Group Title	Portion Control Intervention	Usual Care
Arm/Group Description	Individuals will be given a portion control plate and dietary counseling	Provided with self-help booklets on diet and exercise.
Measure Participants	33	32
Mean (Standard Deviation) [percentage]	-1.7 (3.3)	-0.4 (1.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Portion Control Intervention, Usual Care
	Comments	Data were compared between groups using the 2 sample T-test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.06
	Comments	2 tailed t-test
	Method	t-test, 2 sided
	Comments

2. Primary Outcome

Title	Weight Change at 6 Months
Description	Weight change as a percentage of baseline at post 6 months.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Intent to treat population includes all randomzied subjects. Missing data were imputed using the last observation carried forward.

Arm/Group Title	Portion Control Intervention	Usual Care
Arm/Group Description	Individuals will be given a portion control plate and dietary counseling	Provided with self-help booklets on diet and exercise.
Measure Participants	33	32
Mean (Standard Deviation) [percentage]	-1.2 (3.1)	-0.4 (3.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Portion Control Intervention, Usual Care
	Comments	Data were compared between groups using a 2 sample T-test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.31
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Arm/Group Title	Portion Control Intervention		Usual Care
Arm/Group Description	Individuals will be given a portion control plate and dietary counseling		Provided with self-help booklets on diet and exercise.
All Cause Mortality
	Portion Control Intervention		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Portion Control Intervention		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/32 (0%)
Other (Not Including Serious) Adverse Events
	Portion Control Intervention		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/32 (0%)

Limitations/Caveats

small sample size and inability to blind staff/study subject to the intervenion

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.