OverweightHF2NCT02348853
Healthy Families Healthy Forces Study
A study testing Healthy Weight for Living (HWL) and Current Best Practice (CBP) in people with Overweight and Obesity, run by Tufts University at 1 site in United States.
Trial summary
U.S. Army Medical Research \& Materiel Command Telemedicine and Advanced Technology Research Center (TATRC) is sponsoring the HF2 (Healthy Families, Healthy Forces) Study. This is a randomized trial comparing two different interventions for sustainable weight loss. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Healthy Weight for Living (HWL) and Current Best Practice (CBP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult dependent of active duty (AD) military personnel: an individual who is at least 18 years and have a military identification(ID) card indicating they are a dependent.
- This includes AD military sponsor's children at least 18 years of age (by birth or adoption), spouse, partner, parents, and parent-in-laws)
- At the time of enrollment, willing to be randomized to one of the intervention groups and complete outcome assessments, at least 18 years old at time of provision of informed consent
- BMI at screening greater than or equal to 25.0 kg/m2
- English speaking
- AD military personnel: AD military personnel do not have to meet any criteria other than having an adult partner enrolled in the weight loss program.
Who cannot join
- Adult dependent of AD military personnel: BMI <25
- Pregnant
- Expecting to become pregnant within duration of the study, or lactating
- Prior weight loss surgery
- Concurrent participation in another weight loss program or research study
- Non-English speaking
Show all 27Show fewer
- Currently undergoing divorce proceedings
- Very active individuals (> 2 hours/day vigorous activity)
- Individuals who have lost > 10 lb in the past 6 months
- Individuals with thyroid disease who have had changes in medications within the past 3 months
- Individuals with Type 1 diabetes and individuals with Type 2 diabetes who started using insulin in childhood (before 18 years)
- Those with stomach or intestinal resection, including gastric bypass or other weight loss surgery that influences food intake or absorption of food
- Those with eating disorder such as anorexia, bulimia or binge-eating disorder currently or within the past 5 years
- Those with diagnosis of celiac disease, inflammatory bowel disease or any condition that influences ability to absorb food
- Those with current moderate to severe depression that prevents individual engaging in work or usual activities
- Those with recent unstable heart disease, myocardial infarction
- Active cancer
- Taking medication for severe kidney disease
- Chronic obstructive pulmonary disease
- Immunologic disorders
- AIDS
- Schizophrenia
- Psychosis or bipolar disorder
- Individuals who drink >3 drinks daily or >20 drinks/week
- Individuals with other diseases or taking other medications that impact ability to comply with the intervention core goal of achieving weight loss of 1-2 lb per week through some combination of changing types and amounts of consumed foods and exercise
- Excluded medications include steroids except topical preparations.
- AD military personnel: Those not currently living with the dependent due to separation and/or divorce proceedings will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Tufts University Human Nutrition Research Center on Aging
Boston, Massachusetts, 02111
About this study
Official title: Intervention for Sustainable Weight Loss in Military Families
U.S. Army Medical Research \& Materiel Command Telemedicine and Advanced Technology Research Center (TATRC) is sponsoring the HF2 (Healthy Families, Healthy Forces) Study. This is a randomized trial comparing two different interventions for sustainable weight loss. Specifically, the investigators will compare a "current best practice (CBP)" intervention that includes standard dietary advice with a new, "Healthy Weight for Living (HWL)" intervention that includes recommendations to eat a diet rich in protein, dietary fiber, low glycemic index carbohydrates and low calorie foods. The objective of this study is to compare the CBP and HWL interventions when delivered to adult dependents of active duty (AD) military personnel and measure weight loss effects in both the adult dependents and the AD military personnel they live with.
Read the detailed description
This is a randomized trial comparing two different interventions for sustainable weight loss. Specifically researchers will compare a current best practice (CBP) intervention that includes standard dietary advice with a new Healthy Weight for Living (HWL) intervention that includes recommendations to eat a diet rich in protein, dietary fiber and low glycemic index carbohydrates. The population will be adult dependents of Active Duty (AD) military personnel or retired military personnel (direct intervention participants) and the AD or retired military personnel they live with (indirect intervention participants). The primary outcome will be weight change from baseline to 1 year in the adult dependents. The objective of this study is to compare the CBP and HWL interventions when delivered to adult dependents of AD or retired military personnel and measure weight loss effects in both the adult dependents and the AD or retired military personnel they live with. The working hypothesis is that that the HWL intervention will result in significantly greater weight loss over 1 year than the CBP intervention in an intent-to-treat analysis in adult dependents, and that the greater weight loss in HWL will be associated with greater management of hunger and greater adherence to the goal of reducing energy intake. Weight change up until the 18-24 month period will be measured as a secondary outcome in a cohort of participants who will reach the 18-24 month milestone in the study on or prior to December, 2018. A per protocol analysis will also be applied for comparison of the two weight loss arms. (In addition, weight change will be measured in the participants' AD or retired military personnel partner to test the hypothesis that there is a ripple effect of benefits from the interventions associated with effects in the primary recipients.) The original study plan was to examine weight change over 2 years but due to slower recruiting than anticipated the hypotheses were revised to allow for 1 year to be the primary outcome, with secondary outcomes in the subgroup followed until 18-24 months.
The researchers plan to test our central hypothesis and accomplish the study objectives with the following technical objectives:
- Conduct a randomized trial comparing the HWL intervention to the CBP intervention over 1 year in adult dependents of AD or retired military personnel. The primary outcome will be weight change from baseline to 1 year. The working hypothesis is that randomization to the HWL intervention will result in significantly greater weight loss over 1 year than randomization to the CBP intervention, and that greater weight loss in the HWL intervention will be associated with greater adherence to the goals of reducing energy intake and hunger.
- Compare the change in weight loss of participants in the HWL intervention to the CBP intervention over the 18-24 month timepoints in the subgroup of participants who will reach the 18-24 month milestone on or prior to December, 2018. The working hypothesis is that randomization to the HWL intervention will result in significantly improved weight loss retention compared to randomization to the CBP intervention.
- Examine the effects of the interventions delivered to adult dependents of AD or retired military personnel on the weight of AD or retired military personnel themselves. The working hypothesis, based on preliminary data, is that there will be a "ripple" effect of program benefits from intervention participants to the AD or retired military personnel they live with; specifically, overweight and obese AD or retired military personnel will lose more weight if their partner is randomized to the HWL intervention compared to the CBP intervention, because the weight loss of AD or retired military personnel indirectly exposed to the intervention will be proportional to the weight loss of their adult dependent who is directly exposed.
- Compare the effects of the two interventions on changes in cardiometabolic risk factors. The working hypothesis is that there will be significantly greater improvements between baseline and 1 year in key cardiometabolic risk factors in adult dependents enrolled in the HWL intervention compared to the CBP intervention, and differences between groups will be predicted by differences in weight loss. For a select subgroup of participants who reach the 18-24 month timepoint on or prior to December 2018, the working hypothesis is that there will be significantly greater improvements in between baseline and 2 years in key cardiometabolic risk factors in adult dependents enrolled in the HWL compared to the CBP intervention.
- Conditions
- Overweight, Obesity
- Being tested
- Healthy Weight for Living (HWL), Current Best Practice (CBP)
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Weight for Living (HWL)Behavioural
Current Best Practice (CBP)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Healthy Weight For Living (HWL) | Experimental | HWL is a behavioral intervention designed to effectively facilitate hunger suppression with several concurrent approaches. Hunger suppression is a core behavioral goal of the intervention, and strategies will be used to support that goal, for example increasing meal frequency and encouraging the use of highly satiating low-energy foods to reduce hunger acutely. A unique combination of healthy dietary goals will be recommended that support hunger suppression and/or maintenance of satiety: high total dietary fiber, moderately high protein, moderately low glycemic load (GL) and low energy density. Receives: Behavioral: Healthy Weight for Living (HWL) |
| Current Best Practice (CBP) | Experimental | This intervention is an adapted version of Group Lifestyle Balance which is a validated weight loss program for community groups and military populations that is an official adaptation of the gold standard Diabetes Prevention Program Lifestyle Balance intensive research intervention. It has both training programs for interventionists and program material available on the web and is also slightly modified from the Diabetes Prevention Program study to take into account changing national nutrition recommendations. Receives: Behavioral: Current Best Practice (CBP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change in adult dependents of active duty military
weight change from baseline to 12 months
Measured: Baseline to 12 months
Secondary outcomes (17)
change in systolic and diastolic blood pressure (mmHg)
Measured: baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months
change in total cholesterol (mg/dL)
Measured: baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months
change in HDL cholesterol (mg/dL)
Measured: baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months
change in LDL cholesterol (mg/dL)
Measured: baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months
change in triacylglycerol (mg/dL)
Measured: baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months
change in serum glucose (mg/dL)
Measured: baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months
change in serum insulin (μIU/mL)
Measured: baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months
change in homeostasis model assessment-estimated insulin resistance (HOMA-IR)
Measured: baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months
change in C-reactive protein (CRP)
Measured: baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months
change in HbA1c
Measured: baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months
emotional eating as measured by the Three Factor Eating Questionnaire - r18 (TFEQ-r18)
TFEQ-r18 measures the cognitive and behavioral aspects of eating and has three subscales: cognitive restraint (CR), uncontrolled eating (UE), and emotional eating (EE). The score range for EE is 3 - 12, and higher scores indicate greater emotional eating. The EE subscale has 3 items, each on a 4-point Likert scale (1 - 4). The items are summed up for each subscale, and the total CR, UE, and EE scores are considered separately.
Measured: baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months
food cravings as measured by the Food Craving Questionnaire (FCQ)
Food Cravings Questionnaire - State (FCQ-S) measures situational food cravings. It has 15 items, each of which is on a 5-point Likert scale (1 - 5), and the score range is 15 - 75. Higher scores indicate situational food cravings of greater intensity. Scores on all items are summed up for a total score.
Food Cravings Questionnaire - Trait (FCQ-T) measures frequency and intensity of food cravings. It has 39 items, each of which is on a 6-point Likert scale (1 - 6), and the score range is 39 - 234. Higher scores indicate more frequent and intense food cravings. Scores on all items are summed up for a total score.
Measured: baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months
dietary intake as measured by 24-hour recalls and supermarket receipts
Measured: baseline to 6 months, 12 months, and 18/24 months
uncontrolled eating as measured by the Three Factor Eating Questionnaire - r18 (TFEQ-r18)
TFEQ-r18 measures the cognitive and behavioral aspects of eating and has three subscales: cognitive restraint (CR), uncontrolled eating (UE), and emotional eating (EE). The score range for UE is 9 - 36, and higher scores indicate greater uncontrolled eating. The UE subscale has 9 items, each on a 4-point Likert scale (1 - 4). The items are summed up for each subscale, and the total CR, UE, and EE scores are considered separately.
Measured: baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months
cognitive restraint as measured by the Three Factor Eating Questionnaire - r18 (TFEQ-r18)
TFEQ-r18 measures the cognitive and behavioral aspects of eating and has three subscales: cognitive restraint (CR), uncontrolled eating (UE), and emotional eating (EE). The score range for CR is 6 - 24, and higher scores indicate greater cognitive restraint. The CR subscale has 6 items, each on a 4-point Likert scale (1 - 4). The items are summed up for each subscale, and the total CR, UE, and EE scores are considered separately.
Measured: baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months
Weight change in adult dependents of active duty military, 18-24 months
Weight change up until the 18-24 month period will be measured in a cohort of participants who will reach the 18-24 month milestone in the study on or prior to December, 2018
Measured: baseline to 18 months, 24 months
weight change in active duty military
Measured: baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Army Research Institute of Environmental Medicine
- Responsible party
- Principal investigator, Susan Roberts, Tufts University
- Investigators
- Susan B Roberts, PhD, Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02348853
- Sponsor's protocol ID
- 13035001
- Acronym
- HF2
- Status last verified
- Aug 2020
- First submitted
- 13 Jan 2015
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Das SK, Bukhari AS, Taetzsch AG, Ernst AK, Rogers GT, Gilhooly CH, Hatch-McChesney A, Blanchard CM, Livingston KA, Silver RE, Martin E, McGraw SM, Chin MK, Vail TA, Lutz LJ, Montain SJ, Pittas AG, Lichtenstein AH, Allison DB, Dickinson S, Chen X, Saltzman E, Young AJ, Roberts SB. Randomized trial of a novel lifestyle intervention compared with the Diabetes Prevention Program for weight loss in adult dependents of military service members. Am J Clin Nutr. 2021 Oct 4;114(4):1546-1559. doi: 10.1093/ajcn/nqab259.
PubMed 34375387
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention for Sustainable Weight Loss in Military Families
- ClinicalTrials.gov ID
- NCT02348853
- Acronym / sponsor ID
- HF2 / 13035001
- Conditions
- Overweight, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- United States Army Research Institute of Environmental Medicine
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 28 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
U.S. Army Medical Research \& Materiel Command Telemedicine and Advanced Technology Research Center (TATRC) is sponsoring the HF2 (Healthy Families, Healthy Forces) Study. This is a randomized trial comparing two different interventions for sustainable weight loss. Specifically, the investigators will compare a "current best practice (CBP)" intervention that includes standard dietary advice with a new, "Healthy Weight for Living (HWL)" intervention that includes recommendations to eat a diet rich in protein, dietary fiber, low glycemic index carbohydrates and low calorie foods. The objective of this study is to compare the CBP and HWL interventions when delivered to adult dependents of active duty (AD) military personnel and measure weight loss effects in both the adult dependents and the AD military personnel they live with.
Detailed description
This is a randomized trial comparing two different interventions for sustainable weight loss. Specifically researchers will compare a current best practice (CBP) intervention that includes standard dietary advice with a new Healthy Weight for Living (HWL) intervention that includes recommendations to eat a diet rich in protein, dietary fiber and low glycemic index carbohydrates. The population will be adult dependents of Active Duty (AD) military personnel or retired military personnel (direct intervention participants) and the AD or retired military personnel they live with (indirect intervention participants). The primary outcome will be weight change from baseline to 1 year in the adult dependents. The objective of this study is to compare the CBP and HWL interventions when delivered to adult dependents of AD or retired military personnel and measure weight loss effects in both the adult dependents and the AD or retired military personnel they live with. The working hypothesis is that that the HWL intervention will result in significantly greater weight loss over 1 year than the CBP intervention in an intent-to-treat analysis in adult dependents, and that the greater weight loss in HWL will be associated with greater management of hunger and greater adherence to the goal of reducing energy intake. Weight change up until the 18-24 month period will be measured as a secondary outcome in a cohort of participants who will reach the 18-24 month milestone in the study on or prior to December, 2018. A per protocol analysis will also be applied for comparison of the two weight loss arms. (In addition, weight change will be measured in the participants' AD or retired military personnel partner to test the hypothesis that there is a ripple effect of benefits from the interventions associated with effects in the primary recipients.) The original study plan was to examine weight change over 2 years but due to slower recruiting than anticipated the hypotheses were revised to allow for 1 year to be the primary outcome, with secondary outcomes in the subgroup followed until 18-24 months.
The researchers plan to test our central hypothesis and accomplish the study objectives with the following technical objectives:
- Conduct a randomized trial comparing the HWL intervention to the CBP intervention over 1 year in adult dependents of AD or retired military personnel. The primary outcome will be weight change from baseline to 1 year. The working hypothesis is that randomization to the HWL intervention will result in significantly greater weight loss over 1 year than randomization to the CBP intervention, and that greater weight loss in the HWL intervention will be associated with greater adherence to the goals of reducing energy intake and hunger.
- Compare the change in weight loss of participants in the HWL intervention to the CBP intervention over the 18-24 month timepoints in the subgroup of participants who will reach the 18-24 month milestone on or prior to December, 2018. The working hypothesis is that randomization to the HWL intervention will result in significantly improved weight loss retention compared to randomization to the CBP intervention.
- Examine the effects of the interventions delivered to adult dependents of AD or retired military personnel on the weight of AD or retired military personnel themselves. The working hypothesis, based on preliminary data, is that there will be a "ripple" effect of program benefits from intervention participants to the AD or retired military personnel they live with; specifically, overweight and obese AD or retired military personnel will lose more weight if their partner is randomized to the HWL intervention compared to the CBP intervention, because the weight loss of AD or retired military personnel indirectly exposed to the intervention will be proportional to the weight loss of their adult dependent who is directly exposed.
- Compare the effects of the two interventions on changes in cardiometabolic risk factors. The working hypothesis is that there will be significantly greater improvements between baseline and 1 year in key cardiometabolic risk factors in adult dependents enrolled in the HWL intervention compared to the CBP intervention, and differences between groups will be predicted by differences in weight loss. For a select subgroup of participants who reach the 18-24 month timepoint on or prior to December 2018, the working hypothesis is that there will be significantly greater improvements in between baseline and 2 years in key cardiometabolic risk factors in adult dependents enrolled in the HWL compared to the CBP intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Weight For Living (HWL) | Experimental | Behavioral: Healthy Weight for Living (HWL)HWL is a behavioral intervention designed to effectively facilitate hunger suppression with several concurrent approaches. Hunger suppression is a core behavioral goal of the intervention, and strategies will be used to support that goal, for example increasing meal frequency and encouraging the use of highly satiating low-energy foods to reduce hunger acutely. A unique combination of healthy dietary goals will be recommended that support hunger suppression and/or maintenance of satiety: high total dietary fiber, moderately high protein, moderately low glycemic load (GL) and low energy density. |
| Current Best Practice (CBP) | Experimental | Behavioral: Current Best Practice (CBP)This intervention is an adapted version of Group Lifestyle Balance which is a validated weight loss program for community groups and military populations that is an official adaptation of the gold standard Diabetes Prevention Program Lifestyle Balance intensive research intervention. It has both training programs for interventionists and program material available on the web and is also slightly modified from the Diabetes Prevention Program study to take into account changing national nutrition recommendations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult dependent of active duty (AD) military personnel: an individual who is at least 18 years and have a military identification(ID) card indicating they are a dependent.
- This includes AD military sponsor's children at least 18 years of age (by birth or adoption), spouse, partner, parents, and parent-in-laws)
- At the time of enrollment, willing to be randomized to one of the intervention groups and complete outcome assessments, at least 18 years old at time of provision of informed consent
- BMI at screening greater than or equal to 25.0 kg/m2
- English speaking
Key exclusion criteria (27 listed)
- Adult dependent of AD military personnel: BMI <25
- Pregnant
- Expecting to become pregnant within duration of the study, or lactating
- Prior weight loss surgery
- Concurrent participation in another weight loss program or research study
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 |
|---|---|---|
| Healthy Weight for Living (HWL) | Behavioural | Healthy Weight For Living (HWL) |
| Current Best Practice (CBP) | Behavioural | Current Best Practice (CBP) |
Primary outcome
Weight change in adult dependents of active duty military
Time frame: Baseline to 12 months
weight change from baseline to 12 months
17 secondary outcomes
change in systolic and diastolic blood pressure (mmHg)
Time frame: baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months
change in total cholesterol (mg/dL)
Time frame: baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months
change in HDL cholesterol (mg/dL)
Time frame: baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months
change in LDL cholesterol (mg/dL)
Time frame: baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months
change in triacylglycerol (mg/dL)
Time frame: baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months
change in serum glucose (mg/dL)
Time frame: baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months
change in serum insulin (μIU/mL)
Time frame: baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months
change in homeostasis model assessment-estimated insulin resistance (HOMA-IR)
Time frame: baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months
change in C-reactive protein (CRP)
Time frame: baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months
change in HbA1c
Time frame: baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months
emotional eating as measured by the Three Factor Eating Questionnaire - r18 (TFEQ-r18)
Time frame: baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months
food cravings as measured by the Food Craving Questionnaire (FCQ)
Time frame: baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months
dietary intake as measured by 24-hour recalls and supermarket receipts
Time frame: baseline to 6 months, 12 months, and 18/24 months
uncontrolled eating as measured by the Three Factor Eating Questionnaire - r18 (TFEQ-r18)
Time frame: baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months
cognitive restraint as measured by the Three Factor Eating Questionnaire - r18 (TFEQ-r18)
Time frame: baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months
Weight change in adult dependents of active duty military, 18-24 months
Time frame: baseline to 18 months, 24 months
weight change in active duty military
Time frame: baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
- Derived from this study: PubMed 34375387Das SK, Bukhari AS, Taetzsch AG, Ernst AK, Rogers GT, Gilhooly CH, Hatch-McChesney A, Blanchard CM, Livingston KA, Silver RE, Martin E, McGraw SM, Chin MK, Vail TA, Lutz LJ, Montain SJ, Pittas AG, Lichtenstein AH, Allison DB, Dickinson S, Chen X, Saltzman E, Young AJ, Roberts SB. Randomized trial of a novel lifestyle intervention compared with the Diabetes Prevention Program for weight loss in adult dependents of military service members. Am J Clin Nutr. 2021 Oct 4;114(4):1546-1559. doi: 10.1093/ajcn/nqab259.
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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.
Susan B Roberts, PhD principal investigator
Tufts University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Weight for Living (HWL) and Current Best Practice (CBP) in people with Overweight and Obesity, run by Tufts University 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 27 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 5 Aug 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Weight change in adult dependents of active duty military (time frame: Baseline to 12 months). 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 NCT02348853, which also lists 1 linked publication.
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 5 Aug 2020.