Lose Now North Carolina Community Weight Loss Program

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.

Inclusion Criteria:

1. 18-65 years of age. Older adults have more medical co-morbidities; since this
community program has minimal face-to-face supervision, individuals age >65 will be
ineligible.

2. Body mass index (BMI) greater than 25.0 kg/m2.

3. Access to the internet on at least a weekly basis.

4. Ability to read, write and speak English.

5. Ability to attend 4 monthly group sessions and 2 assessment visits (baseline and
follow-up) at the Nutrition Research Institute.

6. Possession and usage of an internet e-mail address or willingness to sign up for a
free email account (e.g., gmail)

Exclusion Criteria:

1. Pregnancy during the previous 3 months, or planned pregnancy in the folliowing 6
month (study period including assessments and treatment).

2. Current participation in another weight loss study or program (including weight loss
medication) and unwilling to discontinue participation for the duration of the study.

3. Insulin treatment for diabetes mellitus.