Lose Now North Carolina Community Weight Loss Program
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The Lose Now NC research study aims to determine feasibility by delivering a community based
      weight loss program for 4 months in Kannapolis, NC in a large group format compared with
      smaller group format, (recruiting approximately 225 participants from Mecklenburg and
      Cabarrus counties and randomizing them to large or small group in-person sessions coupled
      with an interim internet program) to examine reach and recruitment potential, pilot
      intervention procedures, collect process measures to determine satisfaction, adherence,
      attrition, and estimate weight loss for planning a larger trial.
    

Detailed description: 
      Cancer is the leading cause of death in North Carolina (NC); over 17,400 deaths were
      attributable to cancer in 2009. Obesity is also a widespread problem; 65% of NC adults were
      overweight or obese in 2009. Obesity has been linked to risk of several cancers, most notably
      breast and colon cancer, and also to decreased survival rates. Thus, due to the prevalence
      and linkage of obesity to major cancers, helping adults to lose weight is necessary to reduce
      cancer burden statewide.

      Fortunately, modest weight losses of only 5 to 10 percent of total body weight have been
      shown to improve health and are achievable with behavioral lifestyle modification programs,
      considered the "gold standard" intervention. To date, weight loss via lifestyle modification
      has been shown to be more effective, and more cost-effective, than pharmaceutical
      intervention for reducing risk of chronic disease. However, these "gold standard" programs
      are very time and resource intensive; involving weekly face-to-face (F2F) sessions with
      groups of 10-20 participants for, at minimum, 16-24 weeks followed by bi-weekly contacts for
      up to 2 years. To combat this problem investigators, including those from this investigative
      team, have explored using the Internet to deliver weight loss programs. Internet programs are
      modestly effective producing 4-7% weight loss (at 6 months) or roughly ½ of what intensive
      F2F programs can achieve. Internet programs that involve substantial human contact via e-mail
      produce the best outcomes, yet limit dissemination, and those that involve only automated
      feedback suffer from low utilization over time. What may be optimal is a hybrid model
      involving fewer F2F visits coupled with an Internet program. We are currently investigating
      an alternative F2F approach whereby participants attend F2F visits once per month, as phase 1
      of a 6-step, stepped care approach to treating obesity (R01 HL084400). The initial results
      are promising; at 3 months weight losses did not differ significantly between the monthly F2F
      approach and weekly F2F approach (-15.23 + 10.22 lbs. weekly vs. -12.32 + 10.26 lbs. monthly;
      p>.05). While the monthly program is ¼ of the visits of the standard treatment approach, the
      group size of 20 still severely limits dissemination. Delivering this monthly F2F approach in
      much larger groups (approximately 200 or more), coupled with an Internet program between
      sessions, may represent an effective and disseminable approach for achieving weight loss in
      NC communities.

      A standard behavioral intervention based on the DPP and Premier trials will be adapted for
      this protocol. Behavioral weight control approaches are founded on teaching skills and
      providing the support necessary to enable participants to adopt lower calorie diets (e.g.,
      1500-2000 kcals per day based on starting weight) and moderate physical activity (e.g.,
      walking) to produce energy deficits necessary to produce modest weight losses of 1-2 lbs per
      week. Based on findings from the focus groups and review of study design and expectations
      from the funding source to conduct pilot research that will lead to future funding and
      publishable findings, the main intervention has been finalized (since initial IRB
      submission). The intervention will consist of randomization to either Large Group + Internet
      or Small Group + Internet interventions. The main difference between the two study groups
      will be the size of the monthly group sessions. The internet program delivered in between
      monthly group sessions will be identical. Group sessions will occur at the Nutrition Research
      Institute (NRI) on a monthly basis in months 1 - 4. The internet program will be used between
      group sessions. The monthly sessions will begin with an individual, private, weigh-in,
      followed by a group session. One treatment arm will have large group sessions with
      interactive features and audience participation. The large groups will be comprised of
      approx. 125 participants, last approximately 1 hour, and be facilitated by a weight loss
      expert (dietitian, psychologist, exercise physiologist). The other treatment arm will have
      small group sessions and will consist of approx. 25 participants and will follow traditional
      behavioral weight control group session protocol with facilitation by the above
      named-experts. Participants will be encouraged to enroll in the study with up to two friend
      or family member support partners who are also meet eligibility criteria. Support partners
      will be randomized to the same treatment arm. The F2F sessions are coupled with a
      comprehensive Internet program tested previously by Tate et al that provides the
      self-monitoring tools, tailored automated behavioral feedback, tailored lifestyle content
      (lessons) resources, and social support (e.g. online message board) that participants will be
      encouraged to use in between monthly sessions.
    

Intervention name(s): Group weight loss with companion internet
Intervention type(s): Behavioral
Intervention description(s): Monthly in-person group sessions with an companion internet weight loss intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; Lifestyle Intervention; Group treatment; Internet Intervention