Phone Versus Clinical Approach to Weight Loss

NCT01095458 | Completed DMC

• 2 other identifiers: HSCL16529R01DK076063
• Study Type: interventional
• Target: 395
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Obesity; Phone vs Clinical methods

Outcome Measures

Primary Outcomes (1)

• Equivalent weight loss for phone and clinic groups.

  6 months

Secondary Outcomes (2)

• Equal weight management/regain.

  12 months

• Cost Analysis

  18 months

Study Arms (2)

Phone based weight management group

EXPERIMENTAL

Group based weight management program delivered via conference calls

Behavioral: Phone versus Clinic Weight Management Programs

Clinic based weight management group

EXPERIMENTAL

Traditional clinical based group weight management program

Behavioral: Phone versus Clinic Weight Management Programs

Interventions

Phone versus Clinic Weight Management Programs BEHAVIORAL

To determine if weight loss is equivalent between individuals that complete weight loss meetings in person versus on the phone.

Also known as: Phone based weight management, Clinic based weight management

Clinic based weight management group; Phone based weight management group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Kansas: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Energy Balance Lab, The University of Kansas

Lawrence, Kansas, 66045, United States

Location

Related Publications (2)

• 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.

  PMID: 23408579 RESULT

• 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.

  PMID: 22664647 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joseph E Donnelly, EdD

  University of Kansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 26, 2010
• First Posted: March 30, 2010
• Study Start: July 1, 2007
• Primary Completion: July 1, 2011
• Study Completion: June 1, 2013
• Last Updated: April 4, 2014

Record last verified: 2014-04

Locations

US (1)