PrediabetesFRESHNCT01636258
FRESH Study (Fitness, Relaxation and Eating to Stay Healthy)
A study testing Stress Management, Diet and Exercise in people with Prediabetes and Overweight, run by The Cleveland Clinic at 1 site in United States.
Trial summary
To examine whether a lifestyle program results in weight loss and thereby delays or prevents progression of pre-diabetes to diabetes, we propose a pilot randomized controlled trial of 6 weeks duration with 30 participants held at Stephanie Tubbs Jones Health Center. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Prediabetes, Overweight
- What is being tested?
- Stress Management, Diet and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Study participants must:
- Be capable of giving informed consent
- Understand and voluntarily sign the informed consent form.
- Be females at least 18 years of age and identify themselves as African-American
- Have prediabetes as defined by the American Diabetes Association: history of glycated hemoglobin (HgbA1c) 5.7-6.4 % or fasting blood glucose 100-125 mg/dL (5.6-6.9 mmol/L) (fasting defined as no caloric intake for at least 8 hours), or a 2-hour plasma glucose 140-199 mg/dL (7.8-11.0 mmol/L) during an oral glucose tolerance test (as described by the World Health Organization using a glucose load of 75 g anhydrous glucose dissolved in water)
- Have a body mass index (BMI, defined as weight in kilograms divided by height in meters squared) greater than or equal to 25
Who cannot join
- Current or previous diagnosis of diabetes or a history of HgbA1c ≥ 6.5% or fasting blood glucose ≥ 126 mg/dL (7.0 mmol/L) (fasting defined as no caloric intake for at least 8 hours), or a 2-hour plasma glucose ≥ 200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test or a history of classic symptoms of hyperglycemia or hyperglycemic crisis and a random plasma glucose ≥ 200 mg/dL (11.1 mmol/L).
- Normal glycemia or a currently with a HgbA1c < 5.7% or fasting blood glucose < 100 mg/dL (7.0 mmol/L) (fasting defined as no caloric intake for at least 8 hours), or a 2-hour plasma glucose < 140 mg/dL (11.1 mmol/L) during an oral glucose tolerance test
- Current or past use of oral hypoglycemic agents (including, but not limited to, metformin, rosiglitazone, pioglitazone, glipizide, and glyburide) or insulin
- Male gender
- History of congestive heart failure
- History of renal failure, dialysis, or creatinine greater than 2 mg/dL
Show all 29Show fewer
- History of liver failure or a liver dysfunction with a increase by a factor of 2 above the upper limit of normal in alanine aminotransferase or aspartate aminotransferase
- History of gastrointestinal disorder that would prevent adherence to the recommended diet (e.g. celiac disease, inflammatory bowel disease, history of bariatric surgery, history of intestinal surgery)
- Presence of active cancer
- History of coronary artery disease or cerebrovascular disease
- History of uncontrolled hypertension
- Participation in another lifestyle modification trial
- Pregnancy or lactating or planning to be pregnant
- Current alcoholism or abuse of recreational drugs
- Hospitalization for depression in past 12 months
- Travel plans that do not permit full participation or participant lives too far from Health Center to permit full participation
- History of bariatric surgery, small bowel resection, or extensive bowel resection
- Chronic treatment with systemic steroids
- Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
- Inability to walk two blocks
- Other medial, psychiatric, or behavioral limitations that in the judgment of the principal investigator may interfere with study participation or the ability to follow the intervention protocol
- Amputation of lower limb for nontraumatic causes
- Self report of HIV-positivity or active tuberculosis
- Documented history of pulmonary embolus in past six months
- Chronic obstructive pulmonary disease that would limit ability to follow the study protocol
- Self-reported chronic hepatitis B or C or cirrhosis; inflammatory bowel disease requiring treatment in past year; Cushing's syndrome; acromegaly (clinical diagnosis or self-report); any major organ transplant
- Unwilling or uninterested in participating in group lifestyle education sessions
- Current regular corticosteroid use
- Active polycystic ovarian syndrome
Trial locations and contacts
1 site in 1 country.
United States1 site
Stephanie Tubbs Jones Health Center
East Cleveland, Ohio, 44112
About this study
Official title: Diet, Exercise, Cooking, and Stress Management for Patients With Prediabetes: A Pilot Randomized Controlled Study
To examine whether a lifestyle program results in weight loss and thereby delays or prevents progression of pre-diabetes to diabetes, we propose a pilot randomized controlled trial of 6 weeks duration with 30 participants held at Stephanie Tubbs Jones Health Center. Participants are randomized to receive all of the following: nutrition education, exercise instruction, stress management instruction, and culinary education or follow usual care. Outcomes include: blood sugars and cholesterol, weight, waist circumference, blood pressure, diet, physical activity, perceived stress, and class attendance. Analysis is by Intention to treat analysis of variance. Results will be used to help design larger randomized trial in the future.
Read the detailed description
Control group:
These participants will continue to receive their usual care from their primary medical care team.
Intervention group:
The participants will receive nutrition education, exercise instruction, stress management instruction,and culinary education
- Conditions
- Prediabetes, Overweight
- Being tested
- Stress Management, Diet, Exercise, Culinary education
- Keywords
- Prediabetes, Overweight, African American, Women, Cooking, Nutrition, Exercise, Stress Management
- Medical subject headings
- Prediabetic State, Overweight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress ManagementBehavioural
Every other week
DietBehavioural
Every other week
ExerciseBehavioural
Every week
Culinary educationBehavioural
Every other week
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Control group | No intervention | These participants will continue to receive their usual care from their primary medical care team. |
| Arm B | Experimental | Arm includes diet instruction, exercise, stress management, and culinary education Receives: Behavioral: Stress Management; Behavioral: Diet; Behavioral: Exercise; Behavioral: Culinary education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of "FRESH" Program on Weight Loss
Change in weight measured at baseline and followup (at 8-14 weeks).
Measured: Baseline line and final followup visit (at 8-14 weeks)
Secondary outcomes (4)
Diet - Daily Calorie Intake
Change in daily caloric intake as measured by online 24-hour recall dietary program
Measured: Baseline and final followup visit (at 8-14 weeks)
Exercise
Change in 7-day average steps/day as measured by pedometer at baseline and followup (at 8-14 weeks).
Measured: Baseline and final followup visits (at 8-14 weeks)
Stress
Change of Psychosocial Stress (PSS-10) scores (total range 0-40) measured at baseline and followup (at 8-14 weeks). Higher score reflects worse outcome.
Measured: baseline and followup visit (at 8-14 weeks)
Sleep
Change in self-reported average hours of sleep/night measured at baseline and followup (at 8-14 weeks).
Measured: baseline and followup visit (at 8-14 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionOct 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 The Cleveland ClinicThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda Libertini, The Cleveland Clinic
- Investigators
- Adam M Bernstein, M.D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01636258
- Sponsor's protocol ID
- 12-340
- Acronym
- FRESH
- Status last verified
- May 2022
- First submitted
- 5 Jul 2012
- Last updated
- 10 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bernstein AM, Gendy G, Rudd N, Doyle J, Fay S, Moffett K, Morrison S, Bena J, Cotey S, Roizen MF, Golubic M. Management of prediabetes through lifestyle modification in overweight and obese African-American women: the Fitness, Relaxation, and Eating to Stay Healthy (FRESH) randomized controlled trial. Public Health. 2014 Jul;128(7):674-7. doi: 10.1016/j.puhe.2014.04.005. Epub 2014 Jul 2. No abstract available.
PubMed 24996961
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet, Exercise, Cooking, and Stress Management for Patients With Prediabetes: A Pilot Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01636258
- Acronym / sponsor ID
- FRESH / 12-340
- Conditions
- Prediabetes, Overweight
- Keywords
- Prediabetes, Overweight, African American, Women, Cooking, Nutrition, Exercise, Stress Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 10 Jul 2012 (estimated)
- Results
- Posted 9 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To examine whether a lifestyle program results in weight loss and thereby delays or prevents progression of pre-diabetes to diabetes, we propose a pilot randomized controlled trial of 6 weeks duration with 30 participants held at Stephanie Tubbs Jones Health Center. Participants are randomized to receive all of the following: nutrition education, exercise instruction, stress management instruction, and culinary education or follow usual care. Outcomes include: blood sugars and cholesterol, weight, waist circumference, blood pressure, diet, physical activity, perceived stress, and class attendance. Analysis is by Intention to treat analysis of variance. Results will be used to help design larger randomized trial in the future.
Detailed description
Control group:
These participants will continue to receive their usual care from their primary medical care team.
Intervention group:
The participants will receive nutrition education, exercise instruction, stress management instruction,and culinary education
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Control group | No intervention | –These participants will continue to receive their usual care from their primary medical care team. |
| Arm B | Experimental | Behavioral: Stress Management, Behavioral: Diet, Behavioral: Exercise, Behavioral: Culinary educationArm includes diet instruction, exercise, stress management, and culinary education |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Study participants must:
Key exclusion criteria (29 listed)
- Current or previous diagnosis of diabetes or a history of HgbA1c ≥ 6.5% or fasting blood glucose ≥ 126 mg/dL (7.0 mmol/L) (fasting defined as no caloric intake for at least 8 hours), or a 2-hour plasma glucose ≥ 200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test or a history of classic symptoms of hyperglycemia or hyperglycemic crisis and a random plasma glucose ≥ 200 mg/dL (11.1 mmol/L).
- Normal glycemia or a currently with a HgbA1c < 5.7% or fasting blood glucose < 100 mg/dL (7.0 mmol/L) (fasting defined as no caloric intake for at least 8 hours), or a 2-hour plasma glucose < 140 mg/dL (11.1 mmol/L) during an oral glucose tolerance test
- Current or past use of oral hypoglycemic agents (including, but not limited to, metformin, rosiglitazone, pioglitazone, glipizide, and glyburide) or insulin
- Male gender
- History of congestive heart failure
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 |
|---|---|---|
| Stress ManagementEvery other week | Behavioural | Arm B |
| DietEvery other week | Behavioural | Arm B |
| ExerciseEvery week | Behavioural | Arm B |
| Culinary educationEvery other week | Behavioural | Arm B |
Primary outcome
Effect of "FRESH" Program on Weight Loss
Time frame: Baseline line and final followup visit (at 8-14 weeks)
Change in weight measured at baseline and followup (at 8-14 weeks).
4 secondary outcomes
Diet - Daily Calorie Intake
Time frame: Baseline and final followup visit (at 8-14 weeks)
Exercise
Time frame: Baseline and final followup visits (at 8-14 weeks)
Stress
Time frame: baseline and followup visit (at 8-14 weeks)
Sleep
Time frame: baseline and followup visit (at 8-14 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24996961Bernstein AM, Gendy G, Rudd N, Doyle J, Fay S, Moffett K, Morrison S, Bena J, Cotey S, Roizen MF, Golubic M. Management of prediabetes through lifestyle modification in overweight and obese African-American women: the Fitness, Relaxation, and Eating to Stay Healthy (FRESH) randomized controlled trial. Public Health. 2014 Jul;128(7):674-7. doi: 10.1016/j.puhe.2014.04.005. Epub 2014 Jul 2. No abstract available.
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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.
Adam M Bernstein, M.D. principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress Management, Diet and Exercise in people with Prediabetes and Overweight, run by The Cleveland Clinic 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 6 inclusion and 29 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 10 May 2022. 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?
Yes. Results are posted in the registry (first posted 9 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Effect of "FRESH" Program on Weight Loss (time frame: Baseline line and final followup visit (at 8-14 weeks)). 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 NCT01636258, 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 10 May 2022; AzTrials last refreshed its copy on 8 Nov 2026.