Dissemination of the Look Ahead Weight Management Treatment in the Military

Obesity Clinical Trial

— FITBLUE  

Official title:

Dissemination of the Look Ahead Weight Management Treatment in the Military

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02063178
• Other study ID #: 1R01DK097158-01
• Secondary ID: 1R01DK097158-01
• Status: Completed
• Phase: N/A
• Start date: January 6, 2014
• Est. completion date: June 2018

Study information

• Verified date: September 2018
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 248
• Est. completion date: June 2018
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 Permanent Change of Station/Temporary Duty Assignment/deployment)

3. More than one failure of military-proctored physical fitness test on the last 12 months

4. Uncontrolled hypertension defined as Blood pressure > 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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• Phone-based sessions (28 total) on a structured schedule
28 sessions will be reviewed weekly and then bi-weekly with a trained motivational interviewing counselor for those individuals randomly assigned to the counselor-initiated condition.
• Phone-based sessions upon request
For those individuals randomly assigned to the self-paced condition, the 28 sessions are still available to them, the participant has to call to initiate sessions.
• Weight self-monitoring
Each randomized participant will be given a Body Trace scale that will electronically record their weight.
• Dietary and physical activity self-monitoring
Each randomized participant will be given a free account to Lose It! Premium, an online food/activity diary for self-monitoring.
• Scheduled tailored interventionist feedback
Randomly assigned participants to the counselor-initiated condition will receive feedback on their progress throughout their sessions with their assigned interventionist.
• Dietary goals
Each randomized participant will receive a daily calorie goal range based on their current weight, gender, and BMI.
• Meal replacements
Randomized participants will receive coupons for meal replacements including oatmeal and popcorn.
• Physical activity goals
Each participant will complete the Global Physical Activity Questionnaire which will determine their weekly exercise goals.
• 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.
• 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.
• Tailored interventionist feedback upon request
Randomly assigned participants to the self-paced condition have the option to receive feedback on their progress upon request.

Locations

Country	Name	City	State
United States	Wilford Hall Ambulatory Surgical Center/Lackland Air Force Base	San Antonio	Texas

Sponsors (4)

Lead Sponsor	Collaborator
University of Tennessee	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), United States Air Force, University of Tennessee Health Science Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Weight Loss (Baseline to 12 Months)	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.	12 month intervention
Secondary	The Relationship Between Attendance and Percent Weight Loss	Evaluating the impact of intervention session attendance on percent weight loss outcome, as a measure of adherence.	12 month intervention
Secondary	The Relationship Between Dietary and Physical Activity Self-monitoring Adherence and Percent Weight Loss	We will evaluate the impact of dietary and physical activity self-monitoring adherence (using Lose It website/app) on weight loss outcome.	12 month intervention
Secondary	The Relationship Between Self-weighing on Weight Loss	We will also evaluated the impact of self-weighing (using Body Trace e-scales) on weight loss outcomes.	12 month intervention