Dissemination of the Look Ahead Weight Management Treatment in the Military

NCT02063178 | Completed Results

• 1 other identifier: 1R01DK097158-01
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The Relationship Between Attendance and Percent Weight Loss

  12 month intervention

• The Relationship Between Dietary and Physical Activity Self-monitoring Adherence and Percent Weight Loss

  12 month intervention

• The Relationship Between Self-weighing on Weight Loss

  12 month intervention

Study Arms (2)

Counselor-Initiated

EXPERIMENTAL

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; Behavioral: Challenges

Self-Paced

ACTIVE COMPARATOR

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

Interventions

Phone-based sessions (28 total) on a structured schedule BEHAVIORAL

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.

Counselor-Initiated

Phone-based sessions upon request BEHAVIORAL

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.

Self-Paced

Weight self-monitoring BEHAVIORAL

Each randomized participant will be given a Body Trace scale that will electronically record their weight.

Counselor-Initiated; Self-Paced

Dietary and physical activity self-monitoring BEHAVIORAL

Each randomized participant will be given a free account to Lose It! Premium, an online food/activity diary for self-monitoring.

Counselor-Initiated; Self-Paced

Scheduled tailored interventionist feedback BEHAVIORAL

Randomly assigned participants to the counselor-initiated condition will receive feedback on their progress throughout their sessions with their assigned interventionist.

Counselor-Initiated

Dietary goals BEHAVIORAL

Each randomized participant will receive a daily calorie goal range based on their current weight, gender, and BMI.

Counselor-Initiated; Self-Paced

Meal replacements BEHAVIORAL

Randomized participants will receive coupons for meal replacements including oatmeal and popcorn.

Counselor-Initiated

Physical activity goals BEHAVIORAL

Each participant will complete the Global Physical Activity Questionnaire which will determine their weekly exercise goals.

Counselor-Initiated; Self-Paced

Toolbox BEHAVIORAL

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.

Counselor-Initiated

Challenges BEHAVIORAL

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.

Counselor-Initiated

Tailored interventionist feedback upon request BEHAVIORAL

Randomly assigned participants to the self-paced condition have the option to receive feedback on their progress upon request.

Self-Paced

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Tennessee: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• United States Air Force: collaborator

Study Sites (1)

Wilford Hall Ambulatory Surgical Center/Lackland Air Force Base

San Antonio, Texas, 78236, United States

Location

Related Publications (8)

• Farage G, Simmons C, Kocak M, Klesges RC, Talcott GW, Richey P, Hare M, Johnson KC, Sen S, Krukowski R. Assessing the Contribution of Self-Monitoring Through a Commercial Weight Loss App: Mediation and Predictive Modeling Study. JMIR Mhealth Uhealth. 2021 Jul 14;9(7):e18741. doi: 10.2196/18741.

  PMID: 34259635 DERIVED

• Fahey MC, Klesges RC, Kocak M, Gladney LA, Talcott GW, Krukowski RA. Counselor Efficiency at Providing Feedback in a Technology-Based Behavioral Weight Loss Intervention: Longitudinal Analysis. JMIR Form Res. 2021 May 5;5(5):e23974. doi: 10.2196/23974.

  PMID: 33949954 DERIVED

• Manz KC, Waters TM, Clifton HE, Kocak M, Klesges RC, Talcott GW, Krukowski RA. Cost-Effectiveness of a Weight Loss Intervention: An Adaptation of the Look AHEAD Lifestyle Intervention in the US Military. Obesity (Silver Spring). 2020 Jan;28(1):89-96. doi: 10.1002/oby.22681. Epub 2019 Nov 26.

  PMID: 31773873 DERIVED

• Pebley K, Klesges RC, Talcott GW, Kocak M, Krukowski RA. Measurement Equivalence of E-Scale and In-Person Clinic Weights. Obesity (Silver Spring). 2019 Jul;27(7):1107-1114. doi: 10.1002/oby.22512. Epub 2019 Jun 5.

  PMID: 31168928 DERIVED

• Fahey MC, Klesges RC, Kocak M, Wayne Talcott G, Krukowski RA. Changes in the Perceptions of Self-weighing Across Time in a Behavioral Weight Loss Intervention. Obesity (Silver Spring). 2018 Oct;26(10):1566-1575. doi: 10.1002/oby.22275.

  PMID: 30277031 DERIVED

• Krukowski RA, Hare ME, Talcott GW, Gladney LA, Johnson KC, Richey PA, Kocak M, Keller PL, Hryshko-Mullen A, Klesges RC. Dissemination of the Look AHEAD Intensive Lifestyle Intervention in the United States Military: A Randomized Controlled Trial. Obesity (Silver Spring). 2018 Oct;26(10):1558-1565. doi: 10.1002/oby.22293.

  PMID: 30277030 DERIVED

• Fahey MC, Hare ME, Talcott GW, Kocak M, Hryshko-Mullen A, Klesges RC, Krukowski RA. Characteristics Associated With Participation in a Behavioral Weight Loss Randomized Control Trial in the U.S. Military. Mil Med. 2019 Mar 1;184(3-4):e120-e126. doi: 10.1093/milmed/usy199.

  PMID: 30125001 DERIVED

• Krukowski RA, Hare ME, Talcott GW, Johnson KC, Richey PA, Kocak M, Balderas J, Colvin L, Keller PL, Waters TM, Klesges RC. Dissemination of the Look AHEAD intensive lifestyle intervention in the United States Air Force: study rationale, design and methods. Contemp Clin Trials. 2015 Jan;40:232-9. doi: 10.1016/j.cct.2014.12.014. Epub 2014 Dec 26.

  PMID: 25545025 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Diet

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Results Point of Contact

• Title: Rebecca Krukowski
• Organization: University of Tennessee Health Science Center

rkrukows@uthsc.edu

9014482426

Study Officials

• Rebecca Krukowski, PhD

  University of Tennessee

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2014
• First Posted: February 14, 2014
• Study Start: January 6, 2014
• Primary Completion: March 1, 2017
• Study Completion: June 1, 2018
• Last Updated: February 28, 2019
• Results First Posted: February 28, 2019

Record last verified: 2018-09

Locations

US (1)