Dissemination of the Look Ahead Weight Management Treatment in the Military (FITBLUE)
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About
Purpose: This study aims to take the procedural and research-based lessons learned from a pilot weight loss intervention (IRB # 13-02563-XP), conducted by The University of Tennessee Health Science Center in 2013, and apply them to the current study of 204 active duty military personnel. The pilot study translated and tailored the Look Ahead weight loss intervention to an overweight/obese active duty U.S. Air Force population, while accommodating the lifestyle and environment that is unique to military members and evaluate materials and procedures used.
Rationale: Being overweight is now by far the leading medical reason for rejection in the military. Unfortunately, the impact of weight problems on the military does not stop with those turned away from military service. From 1998 to 2008, the Armed Forces Health Surveillance Center reported the percent of active military members who experienced medical encounters for overweight or obesity significantly increased. The estimated total days of work lost from absenteeism associated with active-duty personnel who are overweight or obese was 658,000. Using Department of Defense (DOD) estimates of average daily based, it was estimated that overweight and obesity costs the DOD $103 million dollars in health care costs annually. Note this estimate is for active duty personnel only. Furthermore, obesity is a major cause for the discharge of uniformed personnel.
The current study is inspired by the successful Look Ahead trial, a behavioral science obesity intervention treatment program that included: a collaborative approach, education, behavioral support, and motivational interviewing. The unique nature of this weight reduction study is significant. To our knowledge, there had not been a successful translation of a highly efficacious obesity treatment in the military until The University of Tennessee Health Science Center implemented a pilot version of the Fit Blue program for active duty U.S. Air Force members in 2013. Following a successful pilot and extant results from the Look Ahead trial, Investigators expect success during the full scale Fit Blue study.
Full description
This study is a weight loss intervention program tailored to a military population. Investigators will randomize 204 consented participants to either an intensive counselor-initiated weight loss intervention or a self-paced weight loss intervention. Neither of the aforementioned conditions are controls and both treatments are expected to result in weight reduction.
Procedures: This is a two-arm individually randomized trial. The Counselor-initiated group will follow a more intense counselor-initiated approach, where the counselor schedules weekly telephone sessions and contacts them directly. The Self-paced group uses a less intense approach, where the participants can receive the same telephone counseling sessions as the counselor-initiated group, only if they call the counselor.
Potential participants will be recruited through the use of advertisements, electronic bulletins, emails, newspapers, and word-of-mouth. Prior to randomization, interested individuals will complete a phone screening, informed consent, two in-person data collection visits and obtain medical clearance, as well as participate in 1 week of dietary and physical activity self-monitoring.
The randomized participants will spend the next year involved in study interventions (either the Counselor-Initiated intervention or the Self-Paced intervention), diet and exercise self-monitoring, daily weighing, and may also include telephone counseling sessions.
The follow-up data collection visits will occur at 4 and 12 months after randomization. At these visits, physical measurements will be collected (i.e. height, weight, abdominal circumference, blood pressure and heart rate) and participants will complete various questionnaires. A Quality of Life questionnaire will also be administered by study personnel.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Active duty military personnel at Joint Base San Antonio in the San Antonio, Texas area
- BMI > 25kg/m2
- English speaking
- Clearance by healthcare provider for participation in study
- >18 years of age
- Participants have at least one year left on their duty assignment at enrollment
Exclusion criteria
- No access to a computer for self-monitoring in Lose It! or email feedback from counselor
- Scheduled extended leave away from the San Antonio area in the next 13 months (i.e. planned Permanent Change of Station/Temporary Duty Assignment/deployment)
- More than one failure of military-proctored physical fitness test on the last 12 months
- Uncontrolled hypertension defined as Blood pressure > 140/90
- A member of the same household is already a FitBlue participant
- Disability or condition that would limit physical activity
- Current use of a weight loss medication
- History of significant kidney or liver disease
- History of uncontrolled thyroid disease or pheochromocytoma
- Malignancy in last 5 years
- History of diabetes treated with a medication that could cause hypoglycemia
- Pregnancy, child birth within the last 6 months, breastfeeding for less than 6 months postpartum, or planning to become pregnant during the study follow-up time (12 months)
- Presence of an unstable psychiatric condition
- Severe asthma, bronchitis, or emphysema that precludes exercise
- History of bariatric surgery or history of significant recent weight loss ( > 10 pounds in past 3 months)
- Other medical or behavioral factors that in the judgement of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
- History of cerebral, coronary, or peripheral vascular disease, uncontrolled cardiac arrhythmia, or uncontrolled congestive heart failure in past 12 months
- Lack of access to telephone
Trial design
Primary purpose
Allocation
Interventional model
Masking
248 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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