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Phone Versus Clinical Approach to Weight Loss

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Phone versus Clinic Weight Management Programs
Sponsored by
University of Kansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Obesity, Phone vs Clinical methods

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18-65 years,
  • BMI between 25 and 39.9,
  • Clearance from PCP.

Exclusion Criteria:

  • Research project within previous 6 months,
  • Exercise > 500 kcal/week,
  • Pregnancy,
  • Serious medical risk,
  • Eating disorders,
  • Use of special diets.

Sites / Locations

  • Energy Balance Lab, The University of Kansas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Phone based weight management group

Clinic based weight management group

Arm Description

Group based weight management program delivered via conference calls

Traditional clinical based group weight management program

Outcomes

Primary Outcome Measures

Equivalent weight loss for phone and clinic groups.

Secondary Outcome Measures

Equal weight management/regain.
Cost Analysis

Full Information

First Posted
March 26, 2010
Last Updated
April 3, 2014
Sponsor
University of Kansas
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT01095458
Brief Title
Phone Versus Clinical Approach to Weight Loss
Official Title
Equivalent Weight Loss for Phone and Clinic Weight Management Programs
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Weight loss and maintenance continues to be problematic for individuals who are overweight or obese. State-of-the-art treatment generally involves a behavioral weight loss clinic that emphasizes nutrition, physical activity, and lifestyle changes and is delivered face-to-face between health educators and small groups of participants. This delivery system is time consuming, expensive, and presents numerous barriers to the participant. We have developed a phone based delivery system that eliminates many of these barriers by substituting group conference calls for clinics and by delivering weight loss materials and products directly to the participant. Hypothesis 1: We expect equivalent weight loss from baseline for phone and clinic groups and have defined equivalence as no greater than 4 kg difference between groups based on our pilot data and potential for clinical significance. Hypothesis 2: During weight maintenance it is likely that participants will experience some weight re-gain. We expect both phone and clinic groups to re-gain a similar amount of weight and that weight for both groups at 18 months will be significantly less than baseline weights. Hypothesis 3: We will complete a cost analysis to determine which delivery method is more economical. Specifically, we expect the phone delivery system to be more cost effective than that of the in-person clinics.
Detailed Description
Weight loss and maintenance continues to be problematic for individuals who are overweight or obese. State-of-the-art treatment is delivered face-to-face between care providers and small groups of participants and this is time consuming, expensive, and presents numerous barriers to the participant such as travel, conflict with work and home, need for child care, loss of anonymity, and others as well as the care provider such as office space, meeting rooms, inventory, etc. A pilot study of a phone based delivery system versus a traditional clinic has been completed with no difference in weight loss. The phone approach may eliminate many of the barriers of a traditional clinic by substituting conference calls for clinics and by delivering weight loss materials and products directly to the participant. In this fashion, the care provider and participants can reside in any location and receive the same information by conference phone call as that provided by clinic, and receive educational materials, weight management products, etc. by air or ground transportation. This proposed investigation is a randomized, equivalency trial to test the effectiveness of a phone based weight management program compared to a traditional face-to-face clinic program for weight loss and weight maintenance. It is expected that at 6 months participants in the phone and clinic groups will show equivalent weight loss and that weight loss will be at least 10% lower than baseline. During weight maintenance some weight gain may occur. However, we expect both phone and clinic groups to gain a similar amount of weight and that weight for both groups at 18 months will be significantly less than baseline weights. A formal cost analysis will be used to determine differences between phone and clinic approaches and extensive process analysis will be used to collect both qualitative and quantitative data to assess how well the programs were implemented as originally designed, challenges and barriers to effective implementation, initial and continual use of program specified activities, quality assurance measures, etc. Relevance: If successful, the phone approach may eliminate many of the barriers inherent to the traditional face-to-face clinic, may be less expensive, and would potentially open weight management to any individual with access to a phone. We believe the likelihood of translation of this research to the public sector would seem reasonable and promising.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Phone vs Clinical methods

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
395 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phone based weight management group
Arm Type
Experimental
Arm Description
Group based weight management program delivered via conference calls
Arm Title
Clinic based weight management group
Arm Type
Experimental
Arm Description
Traditional clinical based group weight management program
Intervention Type
Behavioral
Intervention Name(s)
Phone versus Clinic Weight Management Programs
Other Intervention Name(s)
Phone based weight management, Clinic based weight management
Intervention Description
To determine if weight loss is equivalent between individuals that complete weight loss meetings in person versus on the phone.
Primary Outcome Measure Information:
Title
Equivalent weight loss for phone and clinic groups.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Equal weight management/regain.
Time Frame
12 months
Title
Cost Analysis
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18-65 years, BMI between 25 and 39.9, Clearance from PCP. Exclusion Criteria: Research project within previous 6 months, Exercise > 500 kcal/week, Pregnancy, Serious medical risk, Eating disorders, Use of special diets.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph E Donnelly, EdD
Organizational Affiliation
University of Kansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Energy Balance Lab, The University of Kansas
City
Lawrence
State/Province
Kansas
ZIP/Postal Code
66045
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23408579
Citation
Donnelly JE, Goetz J, Gibson C, Sullivan DK, Lee R, Smith BK, Lambourne K, Mayo MS, Hunt S, Lee JH, Honas JJ, Washburn RA. Equivalent weight loss for weight management programs delivered by phone and clinic. Obesity (Silver Spring). 2013 Oct;21(10):1951-9. doi: 10.1002/oby.20334. Epub 2013 May 25.
Results Reference
result
PubMed Identifier
22664647
Citation
Lambourne K, Washburn RA, Gibson C, Sullivan DK, Goetz J, Lee R, Smith BK, Mayo MS, Donnelly JE. Weight management by phone conference call: a comparison with a traditional face-to-face clinic. Rationale and design for a randomized equivalence trial. Contemp Clin Trials. 2012 Sep;33(5):1044-55. doi: 10.1016/j.cct.2012.05.014. Epub 2012 Jun 1.
Results Reference
derived

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Phone Versus Clinical Approach to Weight Loss

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