University of California, San Francisco
San Francisco, California, 94143-0606, United States
NCT Number: NCT03184337
This pilot study aims to determine whether adding a sleep extension and sleep hygiene intervention to an existing lifestyle improvement program improves its efficacy for weight loss in those at risk for diabetes and cardiovascular disease. Half of the participants will receive the Centers for Disease Control's standard PreventT2 program and half of the participants will receive the same program with an additional sleep intervention.
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Notify Me30 year–70 year
Female
Interventional
Not applicable
San Francisco, California, 94143-0606, United States
The goal of this pilot study is to determine whether the efficacy of an existing lifestyle improvement program can be increased by adding a sleep extension and sleep hygiene intervention. Improved sleep can improve weight loss through two possible routes: lessening fatigue may potentiate physical activity (PA), and decreasing appetite may potentiate diet improvements. A sample of 24-30 women will be assigned to either the Centers for Disease Control's (CDC's) standard PreventT2 program or the same program with an additional integrated sleep intervention. Both programs will involve 8 group sessions administered over 3 months, and all women will be followed for a total of 6 months. The primary outcome is weight loss, and secondary outcomes include sleep quality and duration, physical activity, caloric intake, and physiological indicators of cardiovascular and diabetes risk (HbA1c, HOMA-IR, lipids, blood pressure). The combined program has the potential to significantly improve weight loss in those at risk for diabetes and cardiovascular disease (CVD).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The PreventT2 program will involve 8 group sessions administered over 3 months. It is a behavioral intervention focused on achieving weight loss by improving nutritional intake and increasing physical activity. It will also include individual biweekly phone calls for 6 months.
The CDC's PreventT2 program with added sleep content will involve 8 group sessions administered over 3 months. It is a behavioral intervention focused on achieving weight loss by improving sleep quality and nutritional intake and increasing sleep duration and physical activity. It will also include individual biweekly phone calls for 6 months.
Time frame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Body mass index is calculated as the participant's body weight divided by the square of their height.
Time frame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Nighttime sleep duration will be objectively assessed over 7 days using a Fitbit monitor
Time frame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Daily step counts over 7 days using a Fitbit monitor
Time frame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
International Physical Activity Questionnaire (IPAQ)
Time frame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Daily calories consumed over 7 days and recorded using a Fitbit monitor
Time frame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
'Starting the Conversation' will be used to assess self-reported dietary intake
Time frame: Baseline and 3 months, and 6 months after start of intervention
HbA1c blood tests will be used to measure average blood glucose levels.
Time frame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
FPG will be used to measure current blood glucose levels
Time frame: Baseline and 6 weeks after start of intervention
HOMA-IR is calculated from fasting plasma glucose and insulin levels and will be used to measure insulin resistance.
Time frame: Baseline and 6 weeks after start of intervention
Leptin levels will be used to measure the hormone that regulates satiety
Time frame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
A standard lipid panel will be used to measure cardiovascular risk factors
Time frame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Blood pressure will be used as a measure of cardiovascular risk
Time frame: Baseline and 6 months after start of intervention
Waist circumference will be used to measure central adiposity, an indicator of cardiovascular risk.
Time frame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
The Promis General Health measure will be used to assess the participant's perception of their general health
University of California, San Francisco
Other
Women's Lifestyle and Sleep Intervention for Prediabetes and Metabolic Syndrome
Acronym: LB
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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