OverweightNCT00417599
Preventing Overweight in USAF Personnel: Minimal Contact Program
A study testing Lifestyle Intervention in people with Overweight and Obesity, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The prevalence of overweight in the United States Air Force (USAF) is about 22%. The objective of this study is to compare the effectiveness of a minimal contact behavioral therapy plus usual care group(MCBT+UC) using a controlled experimental comparison of usual care(UC). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2001to Nov 2015
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Within 5 pounds below or equal to their MAW or above MAW according to USAF Weight and height tables
- Access to personal computer with Internet access
- Plan to remain in the local area for one year
- Male or female between the ages 18-55 years
Who cannot join
- Pregnant, planning to become pregnant or becomes pregnant
- Weight loss of more than 10 pounds in the past 3 months
- No prescription or nonprescription weight-loss medication for at least 6 months prior to screening
- On any medical profile. Specific exclusion includes history of myocardial infarction, stroke, or cancer in the past 5 years, diabetes, angina, and orthopedic or joint problems that would prohibit exercise.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wilford Hall Medical Center AFB
San Antonio, Texas, 78236
About this study
The prevalence of overweight in the United States Air Force (USAF) is about 22%. The objective of this study is to compare the effectiveness of a minimal contact behavioral therapy plus usual care group(MCBT+UC) using a controlled experimental comparison of usual care(UC). Subjects are USAF personnel who are 5lbs below their Maximum Allowable Weight (MAW) and heavier. The primary hypothesis is that: MCBT+UC will have significant weight loss as compared to UC.
Read the detailed description
The objective of this study is to compare the relative effectiveness of two approaches to weight management, using a controlled comparison experiment. The two approaches are: Minimal Contact Behavior Therapy Plus Usual Care (MCBT+UC) which includes an orientation meeting, provision of a self-help book, use of an interactive weight management web site for 6 months, and 2 brief motivational interviewing telephone follow-ups, plus usual care;and Usual Care (UC) which includes and orientation meeting and usual care (consisting of required USAF annual physical and fitness exam, participation in any mandatory weight loss or fitness programs, and the requirement to stay below a Maximum Allowable Weight [MAW], with penalties or separation as potential contingencies for failure to remain below MAW). The primary outcome is weight loss.Additional outcomes include body mass index, percent body fat, and waist circumference.
- Conditions
- Overweight, Obesity
- Being tested
- Lifestyle Intervention, control group
- Keywords
- Prevention of overweight, Prevention of obesity, Treatment of overweight, Treatment of obesity
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle InterventionBehavioural
lifestyle intervention .
control groupOther
waiting list control group
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle intervention | Experimental | Behavioral lifestyle intervention versus control group. The Behavioral intervention consists of behavioral lessons delivered over the internet. Receives: Behavioral: Lifestyle Intervention |
| control | Experimental | The intervention for the waiting list control group was usual care. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
Measured: 1 year
Secondary outcomes (3)
Body Mass Index
Measured: 1 year
Percent Body Fat
Measured: 1year
Waist Circumference
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2007 (estimated)
- Study startDec 2001
- Primary completionNov 2015
- Study completionNov 2015
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.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, John P. Foreyt, Baylor College of Medicine
- Investigators
- John P Foreyt, Ph.D., Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00417599
- Sponsor's protocol ID
- H-10880
- Status last verified
- Jun 2016
- First submitted
- 28 Dec 2006
- Last updated
- 24 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: See publication: Hunter CM et al Weight management using the internet: a randomized clinical trial. Am J Prev Med 2998;34:119-126
Publications
Hunter CM, Peterson AL, Alvarez LM, Poston WC, Brundige AR, Haddock CK, Van Brunt DL, Foreyt JP. Weight management using the internet a randomized controlled trial. Am J Prev Med. 2008 Feb;34(2):119-26. doi: 10.1016/j.amepre.2007.09.026.
PubMed 18201641
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Overweight in USAF Personnel: Minimal Contact Program
- ClinicalTrials.gov ID
- NCT00417599
- Acronym / sponsor ID
- H-10880
- Conditions
- Overweight, Obesity
- Keywords
- Prevention of overweight, Prevention of obesity, Treatment of overweight, Treatment of obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Dec 2001
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 1 Jan 2007 (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.
The prevalence of overweight in the United States Air Force (USAF) is about 22%. The objective of this study is to compare the effectiveness of a minimal contact behavioral therapy plus usual care group(MCBT+UC) using a controlled experimental comparison of usual care(UC). Subjects are USAF personnel who are 5lbs below their Maximum Allowable Weight (MAW) and heavier. The primary hypothesis is that: MCBT+UC will have significant weight loss as compared to UC.
Detailed description
The objective of this study is to compare the relative effectiveness of two approaches to weight management, using a controlled comparison experiment. The two approaches are: Minimal Contact Behavior Therapy Plus Usual Care (MCBT+UC) which includes an orientation meeting, provision of a self-help book, use of an interactive weight management web site for 6 months, and 2 brief motivational interviewing telephone follow-ups, plus usual care;and Usual Care (UC) which includes and orientation meeting and usual care (consisting of required USAF annual physical and fitness exam, participation in any mandatory weight loss or fitness programs, and the requirement to stay below a Maximum Allowable Weight [MAW], with penalties or separation as potential contingencies for failure to remain below MAW). The primary outcome is weight loss.Additional outcomes include body mass index, percent body fat, and waist circumference.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle intervention | Experimental | Behavioral: Lifestyle InterventionBehavioral lifestyle intervention versus control group. The Behavioral intervention consists of behavioral lessons delivered over the internet. |
| control | Experimental | Other: control groupThe intervention for the waiting list control group was usual care. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Within 5 pounds below or equal to their MAW or above MAW according to USAF Weight and height tables
- Access to personal computer with Internet access
- Plan to remain in the local area for one year
- Male or female between the ages 18-55 years
Key exclusion criteria (4 listed)
- Pregnant, planning to become pregnant or becomes pregnant
- Weight loss of more than 10 pounds in the past 3 months
- No prescription or nonprescription weight-loss medication for at least 6 months prior to screening
- On any medical profile. Specific exclusion includes history of myocardial infarction, stroke, or cancer in the past 5 years, diabetes, angina, and orthopedic or joint problems that would prohibit exercise.
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 |
|---|---|---|
| Lifestyle Interventionlifestyle intervention . | Behavioural | Lifestyle intervention |
| control groupwaiting list control group | Other | control |
Primary outcome
Body Weight
Time frame: 1 year
3 secondary outcomes
Body Mass Index
Time frame: 1 year
Percent Body Fat
Time frame: 1year
Waist Circumference
Time frame: 1 year
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 24 Jun 2016.
- Derived from this study: PubMed 18201641Hunter CM, Peterson AL, Alvarez LM, Poston WC, Brundige AR, Haddock CK, Van Brunt DL, Foreyt JP. Weight management using the internet a randomized controlled trial. Am J Prev Med. 2008 Feb;34(2):119-26. doi: 10.1016/j.amepre.2007.09.026.
- Individual participant dataSharing planned: Yes. See publication: Hunter CM et al Weight management using the internet: a randomized clinical trial. Am J Prev Med 2998;34:119-126
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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.
John P Foreyt, Ph.D. principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Intervention in people with Overweight and Obesity, run by Baylor College of Medicine 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 4 inclusion and 4 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 24 Jun 2016. 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?
Body Weight (time frame: 1 year). 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 NCT00417599, 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 24 Jun 2016.