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DiabetesPhase 3NCT00569595

Improving Health Habits in Impoverished Populations

A Phase 3 study testing Self-Care Stimulating Disease Prevention Program and Fighting Cancer with Advice in people with Diabetes and Chronic Diseases, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 2 sites 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

Poor diet, physical inactivity, and sedentary behaviors among low-income, minority populations have been linked to greater risk of chronic health conditions such as overweight/obesity, cardiovascular disease, and type 2 diabetes. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Diabetes, Chronic Diseases
What is being tested?
Self-Care Stimulating Disease Prevention Program and Fighting Cancer with Advice
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
2 sitesUnited States
Study dates
Nov 2008to Nov 2009
Phase
Phase 3
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Ages 18 and older
  • English or Spanish-speaking
  • Accessible by telephone or in person over time
  • Willing to cooperate with data collection
  • Planning to be in the Los Angeles area for the next 6 to 12 months so they can complete the study period

Who cannot join

  • Women who are pregnant
  • History of cancer, except non-melanoma skin cancer or in situ cancers
  • Medical conditions preventing free choice of foods (e.g., colitis, poorly-controlled diabetes)
  • Medical conditions precluding participation in common forms of aerobic or resistance exercise (e.g., uncontrolled angina, asthma or hypertension; severe physical impairment; and end-stage disease conditions such as congestive heart failure, nephropathy from any cause, or advanced chronic pulmonary disease)
  • Does not show any desire to change any of their health behaviors (i.e., healthy eating, physical activity, sedentary behavior, or control their weight)

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • UCLA Department of Family Medicine

    Los Angeles, California, 90024

  • Queenscare Family Clinics

    Los Angeles, California, 90028

Other trials in United States

About this study

Poor diet, physical inactivity, and sedentary behaviors among low-income, minority populations have been linked to greater risk of chronic health conditions such as overweight/obesity, cardiovascular disease, and type 2 diabetes. Low-income clinics that serve these populations often represent an untapped opportunity for health promotion in impoverished individuals. This exploratory project proposes to address this scientific gap by introducing and conducting a randomized controlled pilot of the Self-Care Stimulating Disease Prevention Program to address poor dietary habits, physical inactivity, and sedentary lifestyle behaviors among low income, uninsured patient populations.

Read the detailed description

Poor diet, physical inactivity, and sedentary behaviors among low-income, minority populations have been linked to greater risk of chronic health conditions such as overweight/obesity, cardiovascular disease, and type 2 diabetes. Low-income clinics that serve these populations often represent an untapped opportunity for health promotion in impoverished individuals. Few studies have examined the feasibility of using brief physician advice and multi-level, clinic-based interventions to change poor dietary habits, physical inactivity, and sedentary lifestyle behaviors among these culturally diverse populations that comprise the clinic population. This exploratory project proposes to address this scientific gap by introducing and piloting a Self-Care Stimulating Disease Prevention Program (SCSDPP) to address poor dietary habits, physical inactivity, and sedentary lifestyle behaviors among low income, uninsured patient populations (primarily Latinos) served by the community clinics of the Venice Family Clinic (VFC) health center in Los Angeles County. The program will include the development of 1) a simple-to-use patient Health Priority Assessment (HPA) tool designed to assess patient preferences for behavior change; 2) a standard protocol for physicians to provide brief health advice using motivation interviewing (< 2 minutes per visit); 3) a protocol for distributing self-help aids for patient use (e.g., pedometer, exercise videos); and 4) a series of monthly follow-up counseling sessions by lay health educators (e.g., promotores) to help patients address their lifestyle change priorities over time. We will conduct a randomized controlled pilot of the SCSDPP in approximately 100 patient cases at two community health clinics within the VFC health center system. The pilot will utilize precise outcome measures, including commonly-accepted biomarkers (e.g., HgbA1c, fasting blood glucose) and psychometrically-validated measures of process and health status, to accurately assess the magnitude of changes in diet and physical activity among patients over a 12-month observation period. The feasibility of integrating the SCSDPP into the community health clinic setting will be evaluated, and is the primary aim of this project. The results will inform efforts to plan a larger, successor study. Relevance to Public Health: this study evaluates a clinic-based brief intervention to help prevent overweight/obesity, a public health problem that has been linked to the development of the metabolic syndrome and other precursors of diabetes.

Being tested
Self-Care Stimulating Disease Prevention Program, Fighting Cancer with Advice
Keywords
Prevention of Diabetes and other chronic diseases
Medical subject headings
Diabetes Mellitus, Chronic Disease

What participants receive

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

  • Self-Care Stimulating Disease Prevention ProgramBehavioural

    The intervention is aimed at improving diet, increasing physical activity, and reducing sedentary behaviors among low-income patients, assuming that this will increase motivation and self-confidence to adhere to self-care regimens based on personal prioritizing and progressive goal setting.

  • Fighting Cancer with AdviceBehavioural

    Patient health counseling program by lay health educators entitled "Fighting Cancer with Advice."

Study groups in NCT00569595
Study groupRoleWhat they receive
1ExperimentalMulti-Level, Patient-Directed, Lifestyle Change, Health Promotion Program
Receives: Behavioral: Self-Care Stimulating Disease Prevention Program
2Sham comparatorPatient health counseling program by lay health educators Entitled "Fighting Cancer with Advice."
Receives: Behavioral: Fighting Cancer with Advice

What is being measured

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

  1. Serum glycosylated hemoglobin, heart rate recovery step test

    Measured: 4 and 6 months

Secondary outcomes (1)
  1. Total Cholesterol, BMI, waist circumference, healthy eating, physical activity, perceived health status, patient satisfaction, mood

    Measured: 4 and 6 months

Timeline

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

  1. First posted7 Dec 2007 (estimated)
  2. Study startNov 2008
  3. Primary completionNov 2009
  4. Study completionNov 2009

Resources

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00569595
Sponsor's protocol ID
R21 DK71065 (completed)
Other IDs
R21DK071065
Status last verified
Jun 2011
First submitted
5 Dec 2007
Last updated
7 Jun 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Self-Care Stimulating Disease Prevention Program and Fighting Cancer with Advice in people with Diabetes and Chronic Diseases, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 2 sites 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 5 inclusion and 5 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 7 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Serum glycosylated hemoglobin, heart rate recovery step test (time frame: 4 and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 7 Jun 2011.

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