Phone Versus Clinical Approach to Weight Loss
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

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.
    

Intervention name(s): Phone versus Clinic Weight Management Programs
Intervention type(s): Behavioral
Intervention description(s): To determine if weight loss is equivalent between individuals that complete weight loss meetings in person versus on the phone.
Other intervention name(s): Phone based weight management; Clinic based weight management
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Obesity; Phone vs Clinical methods