Phone Versus Clinical Approach to Weight Loss

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Joseph Donnelly, University of Kansas
ClinicalTrials.gov Identifier:
NCT01095458
First received: March 26, 2010
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Obesity
Behavioral: Phone versus Clinic Weight Management Programs

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Equivalent Weight Loss for Phone and Clinic Weight Management Programs

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Equivalent weight loss for phone and clinic groups. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Equal weight management/regain. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Cost Analysis [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 395
Study Start Date: July 2007
Study Completion Date: June 2013
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phone based weight management group
Group based weight management program delivered via conference calls
Behavioral: Phone versus Clinic Weight Management Programs
To determine if weight loss is equivalent between individuals that complete weight loss meetings in person versus on the phone.
Other Names:
  • Phone based weight management
  • Clinic based weight management
Experimental: Clinic based weight management group
Traditional clinical based group weight management program
Behavioral: Phone versus Clinic Weight Management Programs
To determine if weight loss is equivalent between individuals that complete weight loss meetings in person versus on the phone.
Other Names:
  • Phone based weight management
  • Clinic based weight management

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01095458

Locations
United States, Kansas
Energy Balance Lab, The University of Kansas
Lawrence, Kansas, United States, 66045
Sponsors and Collaborators
University of Kansas
Investigators
Principal Investigator: Joseph E Donnelly, EdD University of Kansas
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joseph Donnelly, Professor, University of Kansas
ClinicalTrials.gov Identifier: NCT01095458     History of Changes
Other Study ID Numbers: HSCL16529, R01DK076063
Study First Received: March 26, 2010
Last Updated: April 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
Obesity
Phone vs Clinical methods

Additional relevant MeSH terms:
Obesity
Weight Loss
Body Weight
Body Weight Changes
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 20, 2014