Dissemination of the Look Ahead Weight Management Treatment in the Military (FIT BLUE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Tennessee
Sponsor:
Collaborators:
University of Tennessee Health Science Center
United States Air Force
Information provided by (Responsible Party):
University of Tennessee
ClinicalTrials.gov Identifier:
NCT02063178
First received: February 10, 2014
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Overweight
Obesity
Behavioral: Phone-based sessions (28 total) on a structured schedule
Behavioral: Phone-based sessions upon request
Behavioral: Weight self-monitoring
Behavioral: Dietary and physical activity self-monitoring
Behavioral: Scheduled tailored interventionist feedback
Behavioral: Dietary goals
Behavioral: Meal replacements
Behavioral: Physical activity goals
Behavioral: Toolbox
Behavioral: Challenges
Behavioral: Tailored interventionist feedback upon request

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dissemination of the Look Ahead Weight Management Treatment in the Military

Resource links provided by NLM:


Further study details as provided by University of Tennessee:

Primary Outcome Measures:
  • Examining the percentage of weight loss difference between two arms. [ Time Frame: 12 month intervention ] [ Designated as safety issue: No ]
    The primary data analysis will adhere to the intention-to-treat principle and in the final analysis, the participants will be categorized according to their initial randomization. Investigators will be using the baseline weight as a covariate in the final primary model where the two arms will be compared in terms of the percentage of weight loss.


Secondary Outcome Measures:
  • Examining the impact of attendance on percentage weight loss outcome [ Time Frame: 12 month intervention ] [ Designated as safety issue: No ]
    Investigators also plan to carry out a secondary analysis, evaluating the impact of intervention session attendance on percentage weight loss outcome.

  • Examining the impact of dietary and physical activity self-monitoring on percentage weight loss outcome [ Time Frame: 12 month intervention ] [ Designated as safety issue: No ]
    We will evaluate the impact of dietary and physical activity self-monitoring (using Lose It website/app) on weight loss outcome.

  • Examining the impact of self-weighing on weight loss outcome [ Time Frame: 12 month intervention ] [ Designated as safety issue: No ]
    We will also evaluated the impact of self-weighing (using Body Trace scales and a recommendation to weight daily) on weight loss outcome.


Estimated Enrollment: 204
Study Start Date: December 2013
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Counselor-Initiated
Participants will receive 28 telephone sessions over a 12 month period by interventionists trained in behavior change skills and motivational interviewing techniques. Participants will be asked to monitor food intake and physical activity using the LoseIt website/app and weight daily using a Body Trace e-scale. Participants will receive feedback on self-monitoring through e-mail. Dietary goals will be based on weight and participants' weight-loss progress. Participants will be encouraged to replace 2 meals and a snack with meal replacements (provided). Participants will be asked to gradually increase their moderate to vigorous exercise to 225-250 minutes per week. The Toolbox includes additional treatment options (e.g., food scales, exercise videos, cookbooks) for those who wish to take advantage of them. There will be several challenges that will provide a specific goal (e.g. increase self-monitoring), with a small award for completion.
Behavioral: Phone-based sessions (28 total) on a structured schedule Behavioral: Weight self-monitoring Behavioral: Dietary and physical activity self-monitoring Behavioral: Scheduled tailored interventionist feedback Behavioral: Dietary goals Behavioral: Meal replacements Behavioral: Physical activity goals Behavioral: Toolbox
The toolbox includes additional treatment options for those who wish to take advantage of them. Items may include: food scales, cookbooks, etc. These items may be checked out and must be returned prior to the completion of the study.
Behavioral: Challenges
There will be several challenges designed to increase participant interest and provide a specific goal (e.g., increase self-monitoring). Participants who successfully completed the challenges will be given a small award.
Active Comparator: Self-Paced
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. Participants will be asked to monitor food intake and physical activity using the LoseIt website/app and weight daily using a Body Trace e-scale. Participants will receive feedback on self-monitoring through e-mail only upon request. Dietary goals will be based on weight and participants' weight-loss progress. Participants will be asked to gradually increase their moderate to vigorous exercise to 225-250 minutes per week.
Behavioral: Phone-based sessions upon request Behavioral: Weight self-monitoring Behavioral: Dietary and physical activity self-monitoring Behavioral: Dietary goals Behavioral: Physical activity goals Behavioral: Tailored interventionist feedback upon request

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Active duty military personnel at Joint Base San Antonio in the San Antonio, Texas area
  2. BMI > 25kg/m2
  3. English speaking
  4. Clearance by healthcare provider for participation in study
  5. >18 years of age
  6. Participants have at least one year left on their duty assignment at enrollment

Exclusion Criteria:

  1. No access to a computer for self-monitoring in Lose It! or email feedback from counselor
  2. Scheduled extended leave away from the San Antonio area in the next 13 months (i.e. planned PCS/TDY/deployment)
  3. More than one failure of military-proctored physical fitness test on the last 12 months
  4. Uncontrolled hypertension defined as BP > 140/90
  5. A member of the same household is already a FitBlue participant
  6. Disability or condition that would limit physical activity
  7. Current use of a weight loss medication
  8. History of significant kidney or liver disease
  9. History of uncontrolled thyroid disease or pheochromocytoma
  10. Malignancy in last 5 years
  11. History of diabetes treated with a medication that could cause hypoglycemia
  12. 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)
  13. Presence of an unstable psychiatric condition
  14. Severe asthma, bronchitis, or emphysema that precludes exercise
  15. History of bariatric surgery or history of significant recent weight loss ( > 10 pounds in past 3 months)
  16. 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
  17. History of cerebral, coronary, or peripheral vascular disease, uncontrolled cardiac arrhythmia, or uncontrolled congestive heart failure in past 12 months
  18. Lack of access to telephone
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02063178

Contacts
Contact: Rebecca Krukowski, PhD 901-448-5169 rkrukows@uthsc.edu
Contact: Jennifer Balderas, M.S. 210-671-1085 jbaldera@uthsc.edu

Locations
United States, Texas
Wilford Hall Ambulatory Surgical Center/Lackland Air Force Base Recruiting
San Antonio, Texas, United States, 78236
Contact: Karen Leroy    210-292-3504    kleroy1@uthsc.edu   
Sponsors and Collaborators
University of Tennessee
University of Tennessee Health Science Center
United States Air Force
Investigators
Principal Investigator: Robert Klesges, PhD University of Tennessee Health Science Center
  More Information

No publications provided

Responsible Party: University of Tennessee
ClinicalTrials.gov Identifier: NCT02063178     History of Changes
Other Study ID Numbers: 1R01DK097158-01, 1R01DK097158-01
Study First Received: February 10, 2014
Last Updated: February 12, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014