PreDiabetesLBNCT03184337

Women's Lifestyle Balance Study

A study testing CDC's PreventT2 Program and CDC's PreventT2 Program with Added Sleep Content in people with PreDiabetes and Metabolic Syndrome, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 30 to 70 years, women only
Conditions the study is for: PreDiabetes, Metabolic Syndrome, Overweight
What is being tested?: CDC's PreventT2 Program and CDC's PreventT2 Program with Added Sleep Content
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 siteUnited States
Study dates: 24 Apr 2017to 31 Dec 2017
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 30 to 70 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Female (or self-identify as female)
Age 30-70 years
BMI 25-38 (or 23-38 if Asian or other Pacific Islander)
Time in bed <= 7 hours on a typical weeknight
Meets diagnostic criteria for prediabetes and/or metabolic syndrome

Who cannot join

No regular access to telephone or email (for maintaining contact);
No access to smartphone, tablet, or laptop computer (for using Fitbit);
Having a condition that limits physical activity, such as brisk walking;
Having a diagnosis of type 1 or type 2 diabetes or been previously treated with diabetes medications;
Having a cardiac event or cardiac surgery in the past year;
Having a metabolic condition that prevents weight loss;
Working night shift (Midnight - 4 AM)
Inability to complete the baseline assessment (REDCap survey and Fitbit tracking of activity, diet, and sleep for 7 days)

Trial locations and contacts

1 site in 1 country.

United States1 site

University of California, San Francisco
San Francisco, California, 94143-0606

Other trials in United States

About this study

Official title: Women's Lifestyle and Sleep Intervention for Prediabetes and Metabolic Syndrome

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.

Read the detailed description

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).

Conditions: PreDiabetes, Metabolic Syndrome, Overweight
Being tested: CDC's PreventT2 Program, CDC's PreventT2 Program with Added Sleep Content
Keywords: Weight loss, Women, Sleep, Intervention, Diet, Physical activity, Fitbit
Medical subject headings: Prediabetic State, Metabolic Syndrome, Overweight, Weight Loss, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CDC's PreventT2 ProgramBehavioural
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.
CDC's PreventT2 Program with Added Sleep ContentBehavioural
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.

Study groups in NCT03184337
Study group	Role	What they receive
Active Control	Active comparator	Participants in the active control group will receive 8 group sessions of the CDC's PreventT2 program. Receives: Behavioral: CDC's PreventT2 Program
Experimental	Experimental	Participants in the experimental group will receive 8 group sessions of the CDC's PreventT2 Program with Added Sleep Content designed to extend and improve sleep. Receives: Behavioral: CDC's PreventT2 Program with Added Sleep Content

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in body mass index
Body mass index is calculated as the participant's body weight divided by the square of their height.
Measured: Baseline and 6 weeks, 3 months, and 6 months after start of intervention

Secondary outcomes (14)

Change in sleep duration (objective)
Nighttime sleep duration will be objectively assessed over 7 days using a Fitbit monitor
Measured: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Change in sleep quality (self-report)
Pittsburgh Sleep Quality Index (PSQI)
Measured: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Change in physical activity (objective)
Daily step counts over 7 days using a Fitbit monitor
Measured: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Change in physical activity (self-report)
International Physical Activity Questionnaire (IPAQ)
Measured: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Change in caloric intake
Daily calories consumed over 7 days and recorded using a Fitbit monitor
Measured: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Change in self-reported dietary intake
'Starting the Conversation' will be used to assess self-reported dietary intake
Measured: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Change in HbA1c
HbA1c blood tests will be used to measure average blood glucose levels.
Measured: Baseline and 3 months, and 6 months after start of intervention
Change in Fasting Plasma Glucose (FPG)
FPG will be used to measure current blood glucose levels
Measured: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
HOMA-IR is calculated from fasting plasma glucose and insulin levels and will be used to measure insulin resistance.
Measured: Baseline and 6 weeks after start of intervention
Change in leptin levels
Leptin levels will be used to measure the hormone that regulates satiety
Measured: Baseline and 6 weeks after start of intervention
Change in lipid profile (total cholesterol, LDL, HDL, triglycerides)
A standard lipid panel will be used to measure cardiovascular risk factors
Measured: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Change in blood pressure
Blood pressure will be used as a measure of cardiovascular risk
Measured: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Change in waist circumference
Waist circumference will be used to measure central adiposity, an indicator of cardiovascular risk.
Measured: Baseline and 6 months after start of intervention
Change in self-assessed general health
The Promis General Health measure will be used to assess the participant's perception of their general health
Measured: Baseline and 6 weeks, 3 months, and 6 months after start of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Apr 201731 Dec 2017

First posted12 Jun 2017
Study start24 Apr 2017
Primary completion31 Dec 2017
Study completion31 Dec 2017

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 PreDiabetesStudies of the same condition, open and under way.
More trials run by University of California, San FranciscoThe 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: Non-randomised
Intervention model: Parallel groups
Model description: Participants will be assigned to one of two groups.
Masking: Single blind
Who is masked: Participant
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03184337
Sponsor's protocol ID: LB Study
Acronym: LB
Status last verified: Oct 2018
First submitted: 30 May 2017
Last updated: 25 Oct 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Chesla CA, Gay C, Bauer L, Bender MS, Lee K. Preventing Type 2 Diabetes Among Midlife Women: A Feasibility Study Comparing a Combined Sleep and Lifestyle Intervention With a Standard Lifestyle Intervention. Diabetes Educ. 2020 Oct;46(5):424-434. doi: 10.1177/0145721720943128. Epub 2020 Aug 6.
PubMed 32757824

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All PreDiabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Women's Lifestyle and Sleep Intervention for Prediabetes and Metabolic Syndrome
ClinicalTrials.gov ID: NCT03184337
Acronym / sponsor ID: LB / LB Study
Conditions: PreDiabetes, Metabolic Syndrome, Overweight
Keywords: Weight loss, Women, Sleep, Intervention, Diet, Physical activity, Fitbit
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: University of California, San FranciscoUniversity, hospital or other
Study start: 24 Apr 2017 (actual)
Primary completion: 31 Dec 2017 (actual)
Study completion: 31 Dec 2017 (actual)
First posted: 12 Jun 2017 (actual)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: Participants will be assigned to one of two groups.

Arm	Type	Receives
Active Control	Active comparator	Behavioral: CDC's PreventT2 ProgramParticipants in the active control group will receive 8 group sessions of the CDC's PreventT2 program.
Experimental	Experimental	Behavioral: CDC's PreventT2 Program with Added Sleep ContentParticipants in the experimental group will receive 8 group sessions of the CDC's PreventT2 Program with Added Sleep Content designed to extend and improve sleep.

Who may qualify

Ages: 30 to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Female (or self-identify as female)
Age 30-70 years
BMI 25-38 (or 23-38 if Asian or other Pacific Islander)
Time in bed <= 7 hours on a typical weeknight
Meets diagnostic criteria for prediabetes and/or metabolic syndrome

Key exclusion criteria (8 listed)

No regular access to telephone or email (for maintaining contact);
No access to smartphone, tablet, or laptop computer (for using Fitbit);
Having a condition that limits physical activity, such as brisk walking;
Having a diagnosis of type 1 or type 2 diabetes or been previously treated with diabetes medications;
Having a cardiac event or cardiac surgery in the past year;

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
CDC's PreventT2 ProgramThe 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.	Behavioural	Active Control
CDC's PreventT2 Program with Added Sleep ContentThe 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.	Behavioural	Experimental

Primary outcome

Change in body mass index
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.

14 secondary outcomes

Change in sleep duration (objective)
Time frame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Change in sleep quality (self-report)
Time frame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Change in physical activity (objective)
Time frame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Change in physical activity (self-report)
Time frame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Change in caloric intake
Time frame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Change in self-reported dietary intake
Time frame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Change in HbA1c
Time frame: Baseline and 3 months, and 6 months after start of intervention
Change in Fasting Plasma Glucose (FPG)
Time frame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: Baseline and 6 weeks after start of intervention
Change in leptin levels
Time frame: Baseline and 6 weeks after start of intervention
Change in lipid profile (total cholesterol, LDL, HDL, triglycerides)
Time frame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Change in blood pressure
Time frame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Change in waist circumference
Time frame: Baseline and 6 months after start of intervention
Change in self-assessed general health
Time frame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention

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 25 Oct 2018.
Derived from this study: PubMed 32757824Chesla CA, Gay C, Bauer L, Bender MS, Lee K. Preventing Type 2 Diabetes Among Midlife Women: A Feasibility Study Comparing a Combined Sleep and Lifestyle Intervention With a Standard Lifestyle Intervention. Diabetes Educ. 2020 Oct;46(5):424-434. doi: 10.1177/0145721720943128. Epub 2020 Aug 6.
Individual participant dataSharing planned: No

Related trials for PreDiabetes

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Whole Food for Families: A Pilot RCT of a Dietary Guidelines-Based Intervention to Prevent Type 2 Diabetes
PreDiabetes, Diet, Healthy
Recruiting
Hypothalamic GLP-1 Response in Healthy Weight and Obesity
Obesity, Normal Weight
Not yet recruiting
Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
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Active, not recruiting
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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.

Catherine Chesla, RN, PhD principal investigator

University of California, San Francisco

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 8 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 25 Oct 2018. 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?

Change in body mass index (time frame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention). 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 NCT03184337, 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 25 Oct 2018.