Clinical trial NCT01264393: State-wide Health Approach to Increase Reach and Effectiveness: Study 1
Official title: Using a State-Wide Initiative to Disseminate Effective Behavioral Weight Loss Strategies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2010-12-21
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Behavioral weight loss programs can successfully reduce body weight, but these programs are available to limited numbers of overweight and obese individuals. This project evaluates a unique weight loss approach that combines a self-sustaining weight loss campaign (for outreach) with training in behavioral weight loss strategies and strategies to increase accountability (to improve weight loss success). This innovative combination has the potential to be a cost-effective model for disseminating weight control interventions.

Detailed description: Participants will be randomly assigned to 1 of 3 treatment arms: Shape Up Rhode Island (SURI; a community-based weight loss campaign), SURI plus an Internet-based behavioral weight loss program (SURI + IBWL), or SURI + IBWL + optional group sessions (SURI + IBWL + Group). Primary outcome is weight loss at 12-weeks.

Eligibility criteria: Inclusion Criteria:

1. age 18-70 years
2. Body Mass Index \>25 kg/m2
3. Both genders will be recruited; it is estimated that 70% of participants will be women.
4. All ethnic groups will be recruited, with a goal of recruiting 33% minorities (see below for specific recruitment plans)
5. No health problems that make weight loss or unsupervised exercise unsafe
6. English speaking

Exclusion criteria:

1. report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q; items 1-4). Individuals endorsing joint problems, prescription medication use or other medical conditions that could limit exercise will be required to obtain written physician consent to participate.
2. are currently pregnant or intend to become pregnant in the next 12 months
3. are planning to move outside of the state within the next 12 months
4. have previously participated in the Shape Up Rhode Island 2008 pilot study

Primary outcomes:
measure: Weight change from the initial assessment to the 3-month follow-up assessment measured on a digital scale to the nearest 0.1-kilogram.
timeFrame: 0 to 3 months
Secondary outcomes:
measure: Weight change from the initial assessment to the 6-month follow-up assessment measured on a digital scale to the nearest 0.1-kilogram.
timeFrame: 0 to 6 months
measure: Weight change from the initial assessment to the 12-month follow-up assessment measured on a digital scale to the nearest 0.1-kilogram.
timeFrame: 0 to 12-months
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Miriam Hospital's Weight Control and Diabetes Research Center
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital
name: Rena R. Wing, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wing RR, Crane MM, Thomas JG, Kumar R, Weinberg B. Improving weight loss outcomes of community interventions by incorporating behavioral strategies. Am J Public Health. 2010 Dec;100(12):2513-9. doi: 10.2105/AJPH.2009.183616. Epub 2010 Oct 21.
citation: Naparstek J, Wing RR, Xu X, Leahey TM. Internet-delivered obesity treatment improves symptoms of and risk for depression. Obesity (Silver Spring). 2017 Apr;25(4):671-675. doi: 10.1002/oby.21773. Epub 2017 Feb 22.