OverweightFITBLUENCT02063178
Dissemination of the Look Ahead Weight Management Treatment in the Military
A study testing Phone-based sessions (28 total) on a structured schedule, Phone-based sessions upon request and Weight self-monitoring in people with Overweight and Obesity, run by University of Tennessee at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Phone-based sessions (28 total) on a structured schedule, Phone-based sessions upon request and Weight self-monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2014to Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Wilford Hall Ambulatory Surgical Center/Lackland Air Force Base
San Antonio, Texas, 78236
About this study
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.
Read the 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.
- Conditions
- Overweight, Obesity
- Being tested
- Phone-based sessions (28 total) on a structured schedule, Phone-based sessions upon request, Weight self-monitoring, Dietary and physical activity self-monitoring, Scheduled tailored interventionist feedback
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone-based sessions (28 total) on a structured scheduleBehavioural
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 requestBehavioural
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-monitoringBehavioural
Each randomized participant will be given a Body Trace scale that will electronically record their weight.
Dietary and physical activity self-monitoringBehavioural
Each randomized participant will be given a free account to Lose It! Premium, an online food/activity diary for self-monitoring.
Scheduled tailored interventionist feedbackBehavioural
Randomly assigned participants to the counselor-initiated condition will receive feedback on their progress throughout their sessions with their assigned interventionist.
Dietary goalsBehavioural
Each randomized participant will receive a daily calorie goal range based on their current weight, gender, and BMI.
Meal replacementsBehavioural
Randomized participants will receive coupons for meal replacements including oatmeal and popcorn.
Physical activity goalsBehavioural
Each participant will complete the Global Physical Activity Questionnaire which will determine their weekly exercise goals.
ToolboxBehavioural
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.
ChallengesBehavioural
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 requestBehavioural
Randomly assigned participants to the self-paced condition have the option to receive feedback on their progress upon request.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 month intervention
Secondary outcomes (3)
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.
Measured: 12 month intervention
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.
Measured: 12 month intervention
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.
Measured: 12 month intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study start6 Jan 2014
- Primary completionMar 2017
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), United States Air Force
- Responsible party
- Sponsor
- Investigators
- Rebecca Krukowski, PhD, Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02063178
- Sponsor's protocol ID
- 1R01DK097158-01
- Other IDs
- 1R01DK097158-01
- Acronym
- FITBLUE
- Status last verified
- Sep 2018
- First submitted
- 10 Feb 2014
- Last updated
- 28 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 34259635Fahey 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.
PubMed 33949954Manz 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.
PubMed 31773873Pebley 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.
PubMed 31168928Fahey 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.
PubMed 30277031Krukowski 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.
PubMed 30277030Fahey 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.
PubMed 30125001Krukowski 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.
PubMed 25545025
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissemination of the Look Ahead Weight Management Treatment in the Military
- ClinicalTrials.gov ID
- NCT02063178
- Acronym / sponsor ID
- FITBLUE / 1R01DK097158-01
- Conditions
- Overweight, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), United States Air Force
- Study start
- 6 Jan 2014 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 14 Feb 2014 (estimated)
- Results
- Posted 28 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Counselor-Initiated | Experimental | 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: ChallengesParticipants 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. |
| Self-Paced | Active comparator | 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 requestThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phone-based sessions (28 total) on a structured schedule28 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. | Behavioural | Counselor-Initiated |
| Phone-based sessions upon requestFor 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. | Behavioural | Self-Paced |
| Weight self-monitoringEach randomized participant will be given a Body Trace scale that will electronically record their weight. | Behavioural | Counselor-Initiated, Self-Paced |
| Dietary and physical activity self-monitoringEach randomized participant will be given a free account to Lose It! Premium, an online food/activity diary for self-monitoring. | Behavioural | Counselor-Initiated, Self-Paced |
| Scheduled tailored interventionist feedbackRandomly assigned participants to the counselor-initiated condition will receive feedback on their progress throughout their sessions with their assigned interventionist. | Behavioural | Counselor-Initiated |
| Dietary goalsEach randomized participant will receive a daily calorie goal range based on their current weight, gender, and BMI. | Behavioural | Counselor-Initiated, Self-Paced |
| Meal replacementsRandomized participants will receive coupons for meal replacements including oatmeal and popcorn. | Behavioural | Counselor-Initiated |
| Physical activity goalsEach participant will complete the Global Physical Activity Questionnaire which will determine their weekly exercise goals. | Behavioural | Counselor-Initiated, Self-Paced |
| ToolboxThe 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. | Behavioural | Counselor-Initiated |
| ChallengesThere 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. | Behavioural | Counselor-Initiated |
| Tailored interventionist feedback upon requestRandomly assigned participants to the self-paced condition have the option to receive feedback on their progress upon request. | Behavioural | Self-Paced |
Primary outcome
Percent Weight Loss (Baseline to 12 Months)
Time frame: 12 month intervention
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.
3 secondary outcomes
The Relationship Between Attendance and Percent Weight Loss
Time frame: 12 month intervention
The Relationship Between Dietary and Physical Activity Self-monitoring Adherence and Percent Weight Loss
Time frame: 12 month intervention
The Relationship Between Self-weighing on Weight Loss
Time frame: 12 month intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34259635Farage 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.
- Derived from this study: PubMed 33949954Fahey 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.
- Derived from this study: PubMed 31773873Manz 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.
- Derived from this study: PubMed 31168928Pebley 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.
- Derived from this study: PubMed 30277031Fahey 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.
- Derived from this study: PubMed 30277030Krukowski 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.
- Derived from this study: PubMed 30125001Fahey 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.
- Derived from this study: PubMed 25545025Krukowski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Krukowski, PhD principal investigator
University of Tennessee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phone-based sessions (28 total) on a structured schedule, Phone-based sessions upon request and Weight self-monitoring in people with Overweight and Obesity, run by University of Tennessee at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Weight Loss (Baseline to 12 Months) (time frame: 12 month intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02063178, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2019.