Trial Outcomes & Findings for Dissemination of the Look Ahead Weight Management Treatment in the Military (NCT NCT02063178)

NCT ID: NCT02063178

Last Updated: 2019-02-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

248 participants

Primary outcome timeframe

12 month intervention

Results posted on

2019-02-28

Participant Flow

Participant milestones

Participant milestones
Measure	Counselor-Initiated 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 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.
Overall Study STARTED	124	124
Overall Study COMPLETED	95	77
Overall Study NOT COMPLETED	29	47

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dissemination of the Look Ahead Weight Management Treatment in the Military

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Counselor-Initiated n=124 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. Phone-based sessions (28 total) on a struct	Self-Paced n=124 Participants 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.	Total n=248 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	124 Participants n=5 Participants	124 Participants n=7 Participants	248 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	35.3 years STANDARD_DEVIATION 8.2 • n=5 Participants	33.8 years STANDARD_DEVIATION 6.8 • n=7 Participants	34.6 years STANDARD_DEVIATION 7.5 • n=5 Participants
Sex: Female, Male Female	61 Participants n=5 Participants	61 Participants n=7 Participants	122 Participants n=5 Participants
Sex: Female, Male Male	63 Participants n=5 Participants	63 Participants n=7 Participants	126 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	25 Participants n=5 Participants	31 Participants n=7 Participants	56 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	99 Participants n=5 Participants	93 Participants n=7 Participants	192 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized African American	26 Participants n=5 Participants	23 Participants n=7 Participants	49 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	79 Participants n=5 Participants	84 Participants n=7 Participants	163 Participants n=5 Participants
Race/Ethnicity, Customized Other	19 Participants n=5 Participants	17 Participants n=7 Participants	36 Participants n=5 Participants
Region of Enrollment United States	124 participants n=5 Participants	124 participants n=7 Participants	248 participants n=5 Participants
Weight	88.0 kg STANDARD_DEVIATION 12.9 • n=5 Participants	90.0 kg STANDARD_DEVIATION 15.5 • n=7 Participants	89.0 kg STANDARD_DEVIATION 14.3 • n=5 Participants

PRIMARY outcome

Timeframe: 12 month intervention

Outcome measures

Outcome measures
Measure	Counselor-Initiated n=124 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. Phone-based sessions (28 total) on a struct	Self-Paced n=124 Participants 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.
Percent Weight Loss (Baseline to 12 Months)	2.1 percent weight loss Standard Deviation 4.7	0.0 percent weight loss Standard Deviation 4.0

SECONDARY outcome

Timeframe: 12 month intervention

Evaluating the impact of intervention session attendance on percent weight loss outcome, as a measure of adherence.

Outcome measures

Outcome measures
Measure	Counselor-Initiated n=124 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. Phone-based sessions (28 total) on a struct	Self-Paced n=124 Participants 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.
The Relationship Between Attendance and Percent Weight Loss	0.49 spearman rho correlation	-0.10 spearman rho correlation

SECONDARY outcome

Timeframe: 12 month intervention

We will evaluate the impact of dietary and physical activity self-monitoring adherence (using Lose It website/app) on weight loss outcome.

Outcome measures

Outcome measures
Measure	Counselor-Initiated n=124 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. Phone-based sessions (28 total) on a struct	Self-Paced n=124 Participants 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.
The Relationship Between Dietary and Physical Activity Self-monitoring Adherence and Percent Weight Loss	0.41 Spearman's rho correlation	0.05 Spearman's rho correlation

SECONDARY outcome

Timeframe: 12 month intervention

We will also evaluated the impact of self-weighing (using Body Trace e-scales) on weight loss outcomes.

Outcome measures

Outcome measures
Measure	Counselor-Initiated n=124 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. Phone-based sessions (28 total) on a struct	Self-Paced n=124 Participants 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.
The Relationship Between Self-weighing on Weight Loss	0.41 spearman's rho correlation	-0.11 spearman's rho correlation

Adverse Events

Counselor-Initiated

Serious events: 5 serious events

Other events: 75 other events

Deaths: 0 deaths

Self-Paced

Serious events: 5 serious events

Other events: 55 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Counselor-Initiated n=124 participants at risk 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.	Self-Paced n=124 participants at risk 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.
Gastrointestinal disorders Gastric Carcinoid Tumor	0.81% 1/124 • Number of events 1 • 13 months Participants were asked about adverse events at every data collection visit and if during an intervention session they mentioned a potential adverse event, the interventionist gathered details.	0.00% 0/124 • 13 months Participants were asked about adverse events at every data collection visit and if during an intervention session they mentioned a potential adverse event, the interventionist gathered details.
Skin and subcutaneous tissue disorders Third degree burns	0.00% 0/124 • 13 months Participants were asked about adverse events at every data collection visit and if during an intervention session they mentioned a potential adverse event, the interventionist gathered details.	0.81% 1/124 • Number of events 1 • 13 months Participants were asked about adverse events at every data collection visit and if during an intervention session they mentioned a potential adverse event, the interventionist gathered details.
Surgical and medical procedures Total knee replacement	0.00% 0/124 • 13 months Participants were asked about adverse events at every data collection visit and if during an intervention session they mentioned a potential adverse event, the interventionist gathered details.	0.81% 1/124 • Number of events 1 • 13 months Participants were asked about adverse events at every data collection visit and if during an intervention session they mentioned a potential adverse event, the interventionist gathered details.
Surgical and medical procedures Hysterectomy	0.00% 0/124 • 13 months Participants were asked about adverse events at every data collection visit and if during an intervention session they mentioned a potential adverse event, the interventionist gathered details.	1.6% 2/124 • Number of events 2 • 13 months Participants were asked about adverse events at every data collection visit and if during an intervention session they mentioned a potential adverse event, the interventionist gathered details.
Renal and urinary disorders Kidney problems secondary to antibiotics and dehydration while being treated for an ear infection	0.00% 0/124 • 13 months Participants were asked about adverse events at every data collection visit and if during an intervention session they mentioned a potential adverse event, the interventionist gathered details.	0.81% 1/124 • Number of events 1 • 13 months Participants were asked about adverse events at every data collection visit and if during an intervention session they mentioned a potential adverse event, the interventionist gathered details.
Surgical and medical procedures Tubal ligation	0.00% 0/124 • 13 months Participants were asked about adverse events at every data collection visit and if during an intervention session they mentioned a potential adverse event, the interventionist gathered details.	0.81% 1/124 • Number of events 1 • 13 months Participants were asked about adverse events at every data collection visit and if during an intervention session they mentioned a potential adverse event, the interventionist gathered details.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) New diagnosis of prostate cancer with prostatectomy	0.81% 1/124 • Number of events 1 • 13 months Participants were asked about adverse events at every data collection visit and if during an intervention session they mentioned a potential adverse event, the interventionist gathered details.	0.00% 0/124 • 13 months Participants were asked about adverse events at every data collection visit and if during an intervention session they mentioned a potential adverse event, the interventionist gathered details.
Cardiac disorders Syncope	0.81% 1/124 • Number of events 1 • 13 months Participants were asked about adverse events at every data collection visit and if during an intervention session they mentioned a potential adverse event, the interventionist gathered details.	0.00% 0/124 • 13 months Participants were asked about adverse events at every data collection visit and if during an intervention session they mentioned a potential adverse event, the interventionist gathered details.
Musculoskeletal and connective tissue disorders Tibial osteotomy and osteochondral allograft transfer	0.81% 1/124 • Number of events 1 • 13 months Participants were asked about adverse events at every data collection visit and if during an intervention session they mentioned a potential adverse event, the interventionist gathered details.	0.00% 0/124 • 13 months Participants were asked about adverse events at every data collection visit and if during an intervention session they mentioned a potential adverse event, the interventionist gathered details.
Psychiatric disorders Alcoholism	0.81% 1/124 • Number of events 1 • 13 months Participants were asked about adverse events at every data collection visit and if during an intervention session they mentioned a potential adverse event, the interventionist gathered details.	0.00% 0/124 • 13 months Participants were asked about adverse events at every data collection visit and if during an intervention session they mentioned a potential adverse event, the interventionist gathered details.

Other adverse events

Other adverse events
Measure	Counselor-Initiated n=124 participants at risk 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.	Self-Paced n=124 participants at risk 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.
Musculoskeletal and connective tissue disorders Ankle injury	10.5% 13/124 • Number of events 13 • 13 months Participants were asked about adverse events at every data collection visit and if during an intervention session they mentioned a potential adverse event, the interventionist gathered details.	7.3% 9/124 • Number of events 9 • 13 months Participants were asked about adverse events at every data collection visit and if during an intervention session they mentioned a potential adverse event, the interventionist gathered details.
Musculoskeletal and connective tissue disorders Back injury	13.7% 17/124 • Number of events 17 • 13 months Participants were asked about adverse events at every data collection visit and if during an intervention session they mentioned a potential adverse event, the interventionist gathered details.	13.7% 17/124 • Number of events 17 • 13 months Participants were asked about adverse events at every data collection visit and if during an intervention session they mentioned a potential adverse event, the interventionist gathered details.
Respiratory, thoracic and mediastinal disorders Common cold	10.5% 13/124 • Number of events 13 • 13 months Participants were asked about adverse events at every data collection visit and if during an intervention session they mentioned a potential adverse event, the interventionist gathered details.	4.8% 6/124 • Number of events 6 • 13 months Participants were asked about adverse events at every data collection visit and if during an intervention session they mentioned a potential adverse event, the interventionist gathered details.
Musculoskeletal and connective tissue disorders Foot injury	9.7% 12/124 • Number of events 12 • 13 months Participants were asked about adverse events at every data collection visit and if during an intervention session they mentioned a potential adverse event, the interventionist gathered details.	8.1% 10/124 • Number of events 10 • 13 months Participants were asked about adverse events at every data collection visit and if during an intervention session they mentioned a potential adverse event, the interventionist gathered details.
Musculoskeletal and connective tissue disorders Knee injury	10.5% 13/124 • Number of events 14 • 13 months Participants were asked about adverse events at every data collection visit and if during an intervention session they mentioned a potential adverse event, the interventionist gathered details.	9.7% 12/124 • Number of events 12 • 13 months Participants were asked about adverse events at every data collection visit and if during an intervention session they mentioned a potential adverse event, the interventionist gathered details.
Musculoskeletal and connective tissue disorders Wrist injury	5.6% 7/124 • Number of events 7 • 13 months Participants were asked about adverse events at every data collection visit and if during an intervention session they mentioned a potential adverse event, the interventionist gathered details.	0.81% 1/124 • Number of events 1 • 13 months Participants were asked about adverse events at every data collection visit and if during an intervention session they mentioned a potential adverse event, the interventionist gathered details.

Additional Information

Rebecca Krukowski

University of Tennessee Health Science Center

Phone: 9014482426

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place