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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

March 26, 2010
April 3, 2014
July 2007
July 2011   (final data collection date for primary outcome measure)
Equivalent weight loss for phone and clinic groups. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01095458 on ClinicalTrials.gov Archive Site
  • Equal weight management/regain. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Cost Analysis [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Phone Versus Clinical Approach to Weight Loss
Equivalent Weight Loss for Phone and Clinic Weight Management Programs

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Obesity
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: Phone based weight management group
    Group based weight management program delivered via conference calls
    Intervention: Behavioral: Phone versus Clinic Weight Management Programs
  • Experimental: Clinic based weight management group
    Traditional clinical based group weight management program
    Intervention: Behavioral: Phone versus Clinic Weight Management Programs

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
395
June 2013
July 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01095458
HSCL16529, R01DK076063
Yes
Joseph Donnelly, University of Kansas
University of Kansas
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Joseph E Donnelly, EdD University of Kansas
University of Kansas
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP