Completed
Intervention Study in Women Wanting to Lose Weight (Women's Health Project)
What is being tested
Diet, exercise, sleep hygiene counseling
+ Diet and exercise counseling
Behavioral
Who is being recruted
Behavior+11
+ Body Weight
+ Body Weight Changes
From 18 to 70 Years
+5 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Study Start: September 2012
Summary
Principal SponsorTexas Tech University Health Sciences Center
Last updated: May 1, 2014
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2012
Actual date on which the first participant was enrolled.None needed
Principal SponsorTexas Tech University Health Sciences Center
Last updated: May 1, 2014
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Female
Biological sex of participants that are eligible to enroll.From 18 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
BehaviorBody WeightBody Weight ChangesNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsHealth BehaviorOvernutritionOverweightSleep HygieneMotor ActivityObesityWeight Loss
Criteria
2 inclusion criteria required to participate
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)
3 exclusion criteria prevent from participating
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalSubjects 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.
Group II
Active ComparatorSubjects 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.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Texas Tech Health Sciences Center - Physicians Pavillion, Internal Medicine Clinic
Lubbock, United StatesOpen Texas Tech Health Sciences Center - Physicians Pavillion, Internal Medicine Clinic in Google MapsCompletedOne Study Center