Women's Health Project for Women Wanting to Lose Weight

NCT01671397 | Completed

• 1 other identifier: 041923
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Obesity

Keywords

Obesity; weight loss; sleep hygiene; diet; exercise

Outcome Measures

Primary Outcomes (1)

• 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.

  Six months

Secondary Outcomes (1)

• Functional capacity

  6 months

Other Outcomes (2)

• Lipid profile

  Six months

• Quality of life indices

  Six months

Study Arms (2)

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.

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.

Behavioral: Diet and exercise counseling

Interventions

Diet and exercise counseling BEHAVIORAL

Not needed

Diet and exercise counseling

Diet, exercise, sleep hygiene counseling BEHAVIORAL

None needed

Diet, exercise, sleep hygiene counseling

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (1)

Texas Tech Health Sciences Center - Physicians Pavillion, Internal Medicine Clinic

Lubbock, Texas, 79430, United States

Location

MeSH Terms

Conditions

Obesity; Weight Loss; Sleep Hygiene; Motor Activity

Interventions

Diet; Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kenneth M Nugent, MD

  Texas Tech University Health Sciences Center

  PRINCIPAL INVESTIGATOR

• Dolores M Buscemi, MD

  Texas Tech University Health Sciences Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2012
• First Posted: August 23, 2012
• Study Start: September 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: May 1, 2014

Record last verified: 2014-04

Locations

US (1)