ObesityNCT01671397
Women's Health Project for Women Wanting to Lose Weight
A study testing Diet and exercise counseling and Diet, exercise, sleep hygiene counseling in people with Obesity, run by Texas Tech University Health Sciences Center at 1 site in United States.
Trial summary
The prevalence of obesity has steadily increased in the United States. This can lead to the worsening of type 2 diabetes mellitus, hypertension, sleep apnea, coronary artery disease and osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Diet and exercise counseling and Diet, exercise, sleep hygiene counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Feb 2014
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any woman between the ages of 18 and 70 who is interested in counseling for weight loss
- The body mass index (BMI) must be over 25 (overweight category) and below 40 (morbidly obese)
Who cannot join
- Women who cannot reasonably expect to commit the time needed for 6 visits, two lab draws, and completion of three one week sleep logs
- Women who have had recent hospitalization or major surgery and cannot participate in a self directed exercise program
- Women with significant cardiac or respiratory disease and cannot participate in a self directed exercise program
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech Health Sciences Center - Physicians Pavillion, Internal Medicine Clinic
Lubbock, Texas, 79430
About this study
Official title: Intervention Study in Women Wanting to Lose Weight (Women's Health Project)
The prevalence of obesity has steadily increased in the United States. This can lead to the worsening of type 2 diabetes mellitus, hypertension, sleep apnea, coronary artery disease and osteoarthritis. The medical management of obesity involves dietary counseling and education, behavioral counseling with goal setting, and exercise. Patients with short sleep periods in the range of 5 to 7 hours per night are often heavier than normal sleepers even after controlling for other factors. We hypothesize that the addition of focused counseling on healthy sleeping to counseling on healthy eating (dieting) and healthy exercise can help women lose weight.
Read the detailed description
None needed
- Conditions
- Obesity
- Being tested
- Diet and exercise counseling, Diet, exercise, sleep hygiene counseling
- Keywords
- Obesity, weight loss, sleep hygiene, diet, exercise
- Medical subject headings
- Obesity, Weight Loss, Sleep Hygiene, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet and exercise counselingBehavioural
Not needed
Diet, exercise, sleep hygiene counselingBehavioural
None needed
| Study group | Role | What they receive |
|---|---|---|
| Diet, exercise, sleep hygiene counseling | Experimental | Subjects will meet with a dietitian and a physician and receive counseling on diet restriction, exercise goals, and good sleep hygiene. Subjects will identify goals in each domain and keep a calendar of the success with achieving these goals. Receives: Behavioral: Diet, exercise, sleep hygiene counseling |
| Diet and exercise counseling | Active comparator | Subjects will meet with a dietitian and a physician and receive counseling on calorie restriction and exercise. They will identify goals in each domain and keep a calendar to determine their success with achieving these goals. Receives: Behavioral: Diet and exercise counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Patients will be monitored for weight loss over a six month study period. We estimate that the sleep hygiene intervention group will lose 10 pounds more than the control group.
Measured: Six months
Secondary outcomes (1)
Functional capacity
We will measure functional capacity using gait speed, timed "Get-up and Go" test, and standing balance at baseline and at six months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kenneth M Nugent, MD, Principal investigator, Texas Tech University Health Sciences CenterDolores M Buscemi, MD, Study director, Texas Tech University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01671397
- Sponsor's protocol ID
- 041923
- Status last verified
- Apr 2014
- First submitted
- 20 Aug 2012
- Last updated
- 1 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Study in Women Wanting to Lose Weight (Women's Health Project)
- ClinicalTrials.gov ID
- NCT01671397
- Acronym / sponsor ID
- 041923
- Conditions
- Obesity
- Keywords
- Obesity, weight loss, sleep hygiene, diet, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 23 Aug 2012 (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 obesity has steadily increased in the United States. This can lead to the worsening of type 2 diabetes mellitus, hypertension, sleep apnea, coronary artery disease and osteoarthritis. The medical management of obesity involves dietary counseling and education, behavioral counseling with goal setting, and exercise. Patients with short sleep periods in the range of 5 to 7 hours per night are often heavier than normal sleepers even after controlling for other factors. We hypothesize that the addition of focused counseling on healthy sleeping to counseling on healthy eating (dieting) and healthy exercise can help women lose weight.
Detailed description
None needed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet, exercise, sleep hygiene counseling | Experimental | Behavioral: Diet, exercise, sleep hygiene counselingSubjects will meet with a dietitian and a physician and receive counseling on diet restriction, exercise goals, and good sleep hygiene. Subjects will identify goals in each domain and keep a calendar of the success with achieving these goals. |
| Diet and exercise counseling | Active comparator | Behavioral: Diet and exercise counselingSubjects will meet with a dietitian and a physician and receive counseling on calorie restriction and exercise. They will identify goals in each domain and keep a calendar to determine their success with achieving these goals. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Any woman between the ages of 18 and 70 who is interested in counseling for weight loss
- The body mass index (BMI) must be over 25 (overweight category) and below 40 (morbidly obese)
Key exclusion criteria (3 listed)
- Women who cannot reasonably expect to commit the time needed for 6 visits, two lab draws, and completion of three one week sleep logs
- Women who have had recent hospitalization or major surgery and cannot participate in a self directed exercise program
- Women with significant cardiac or respiratory disease and cannot participate in a self directed exercise program
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 |
|---|---|---|
| Diet and exercise counselingNot needed | Behavioural | Diet and exercise counseling |
| Diet, exercise, sleep hygiene counselingNone needed | Behavioural | Diet, exercise, sleep hygiene counseling |
Primary outcome
Weight loss
Time frame: Six months
Patients will be monitored for weight loss over a six month study period. We estimate that the sleep hygiene intervention group will lose 10 pounds more than the control group.
1 secondary outcome
Functional capacity
Time frame: 6 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 1 May 2014.
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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.
Kenneth M Nugent, MD principal investigator
Texas Tech University Health Sciences Center
Dolores M Buscemi, MD study director
Texas Tech University Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet and exercise counseling and Diet, exercise, sleep hygiene counseling in people with Obesity, run by Texas Tech University Health Sciences Center 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 2 inclusion and 3 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 1 May 2014. 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 loss (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2014.