Cardiovascular DiseasesCLIPNCT00119795
Exercise and Weight Loss for Improving Mobility in Older Adults Who Are Obese
A study testing Exercise and Weight Loss in people with Cardiovascular Diseases and Heart Diseases, run by Wake Forest University Health Sciences at 3 sites in United States.
Trial summary
To test the effects of exercise and weight loss on mobility disability of older overweight/obese men and women who have evidence of cardiovascular disease or the metabolic syndrome. Read more about this study
- Who is it for?
- Ages 60 to 79 years
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Metabolic Syndrome X
- What is being tested?
- Exercise and Weight Loss
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2005to Apr 2011
- 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 60 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently living in one of the counties surrounding Winston-Salem, NC
- Sedentary (engages in fewer than 30 minutes of moderate structured physical activity for at least 10 minutes at a time each week)
- Overweight or obese, as defined by a body mass index (BMI) greater than 25
- Fasting glucose level less than 140
- Documented evidence of an MI, PCTA, chronic stable angina, or cardiovascular surgery (coronary artery or valvular heart disease) within the 6 months prior to study entry or an ATP III diagnosis of the metabolic syndrome
- Disability defined as self-reported difficulty with walking ¼ mile, climbing stairs, lifting and carrying groceries, or performing other household chores such as cleaning and yard work
- Does not plan to move out of the county of residence for the duration of the study
Who cannot join
- Diagnosis of bipolar depression or schizophrenia (defined as self-reported treatment for these conditions)
- Currently receiving lithium or neuroleptics
- Evidence of unstable angina, symptomatic congestive heart failure, or exercise-induced complex ventricular arrhythmias
- Resting blood pressure greater than 160/100 mmHg
- Diagnosis of any of the following: Parkinson's disease; chronic liver disease (cirrhosis, chronic hepatitis, etc.); systemic rheumatic condition (rheumatoid arthritis, psoriatic arthritis, Reiter's disease, systemic lupus erythematosus, etc.); end stage renal disease; or other systemic diseases or abnormal laboratory values which would preclude participants from safely participating in the protocol or impair their ability to complete the study
- Actively being treated for cancer (other than non-melanotic skin cancer)
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- Significant visual or hearing impairment that cannot be corrected and results in the inability to use the telephone or hear normal conversation
- Currently participating in or planning to participate in another medical intervention study
- Current alcohol abuse disorder or consumes more than 21 alcoholic drinks per week
- Unable to walk without assistance
- Unable to speak or read English
- Judged by the clinic staff to be unsuitable for the trial for any reason
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Guilford County, North Carolina Cooperative Extension Center
Greensboro, North Carolina, 27405
Davidson County Coopertive Extension
Lexington, North Carolina, 27292
Forsyth County Cooperative Extension Center
Winston-Salem, North Carolina, 27105
About this study
Official title: Cooperative Lifestyle Intervention Program (CLIP)
To test the effects of exercise and weight loss on mobility disability of older overweight/obese men and women who have evidence of cardiovascular disease or the metabolic syndrome.
Read the detailed description
BACKGROUND:
Older adults make up the fastest growing segment of our population. It is estimated that by the year 2030, elderly people will make up 22% of the United States population. A large portion of older adults suffers from one or more chronic conditions that could be improved by regular physical activity. Therefore, research in this age group is needed.
DESIGN NARRATIVE:
The Cooperative Lifestyle Intervention Program (CLIP) will test the effects of a physical activity intervention and a weight loss intervention on mobility disability of overweight or obese men and women who have evidence of cardiovascular disease or the metabolic syndrome. The public health relevance of the trial lies in the fact that the interventions will be delivered in conjunction with four Cooperative Extension Centers in counties surrounding Winston-Salem, North Carolina. CLIP will be designed as a three arm, randomized, controlled trial. The three 18-month treatments will include: (1) a basic health education-based control condition, (2) a group treatment program for physical activity, and (3) a lifestyle intervention designed to reduce sedentary behavior and promote weight loss. The primary aim will be to compare the effects of the three treatment arms on the change in performance on a 400-meter walk test over the course of 18 months. Secondary aims will include changes in cardiovascular risk factors, adiposity, cardiovascular fitness, physical activity, and health-related quality of life. Analyses will also be conducted to determine whether changes in the primary outcome are mediated by changes in constructs from social cognitive theory.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Metabolic Syndrome X, Obesity
- Being tested
- Exercise, Weight Loss, Health Education Control
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Metabolic Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Also called Physical activity
Increase Physical Activity to 150 min/wk
Weight LossBehavioural
Also called Diet modification
Lose 7-10% of body weight and increase physical activity to 150 min/wk
Health Education ControlBehavioural
Also called Attention control
Lectures on information relevant to successful aging
| Study group | Role | What they receive |
|---|---|---|
| Health education control | Active comparator | This is an education program for older adults entitles, successful aging. Receives: Behavioral: Health Education Control |
| Exercise Only | Experimental | Structured exercise 150 min/wk Receives: Behavioral: Exercise |
| Weight Loss | Experimental | Behavioral weight loss; goal of 7% Receives: Behavioral: Weight Loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
400 meter walk
Measured: Measured at 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2005 (estimated)
- Study startAug 2005
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Walter Rejeski, Principal investigator, Wake Forest University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00119795
- Sponsor's protocol ID
- 197
- Other IDs
- R01HL076441, R01HL076441-01
- Acronym
- CLIP
- Status last verified
- Aug 2018
- First submitted
- 6 Jul 2005
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brawley L, Rejeski WJ, Gaukstern JE, Ambrosius WT. Social cognitive changes following weight loss and physical activity interventions in obese, older adults in poor cardiovascular health. Ann Behav Med. 2012 Dec;44(3):353-64. doi: 10.1007/s12160-012-9390-5.
PubMed 22773225Rejeski WJ, Brubaker PH, Goff DC Jr, Bearon LB, McClelland JW, Perri MG, Ambrosius WT. Translating weight loss and physical activity programs into the community to preserve mobility in older, obese adults in poor cardiovascular health. Arch Intern Med. 2011 May 23;171(10):880-6. doi: 10.1001/archinternmed.2010.522. Epub 2011 Jan 24.
PubMed 21263080
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cooperative Lifestyle Intervention Program (CLIP)
- ClinicalTrials.gov ID
- NCT00119795
- Acronym / sponsor ID
- CLIP / 197
- Conditions
- Cardiovascular Diseases, Heart Diseases, Metabolic Syndrome X, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 2005
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 14 Jul 2005 (estimated)
- 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.
To test the effects of exercise and weight loss on mobility disability of older overweight/obese men and women who have evidence of cardiovascular disease or the metabolic syndrome.
Detailed description
BACKGROUND:
Older adults make up the fastest growing segment of our population. It is estimated that by the year 2030, elderly people will make up 22% of the United States population. A large portion of older adults suffers from one or more chronic conditions that could be improved by regular physical activity. Therefore, research in this age group is needed.
DESIGN NARRATIVE:
The Cooperative Lifestyle Intervention Program (CLIP) will test the effects of a physical activity intervention and a weight loss intervention on mobility disability of overweight or obese men and women who have evidence of cardiovascular disease or the metabolic syndrome. The public health relevance of the trial lies in the fact that the interventions will be delivered in conjunction with four Cooperative Extension Centers in counties surrounding Winston-Salem, North Carolina. CLIP will be designed as a three arm, randomized, controlled trial. The three 18-month treatments will include: (1) a basic health education-based control condition, (2) a group treatment program for physical activity, and (3) a lifestyle intervention designed to reduce sedentary behavior and promote weight loss. The primary aim will be to compare the effects of the three treatment arms on the change in performance on a 400-meter walk test over the course of 18 months. Secondary aims will include changes in cardiovascular risk factors, adiposity, cardiovascular fitness, physical activity, and health-related quality of life. Analyses will also be conducted to determine whether changes in the primary outcome are mediated by changes in constructs from social cognitive theory.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Health education control | Active comparator | Behavioral: Health Education ControlThis is an education program for older adults entitles, successful aging. |
| Exercise Only | Experimental | Behavioral: ExerciseStructured exercise 150 min/wk |
| Weight Loss | Experimental | Behavioral: Weight LossBehavioral weight loss; goal of 7% |
Who may qualify
- Ages
- 60 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Currently living in one of the counties surrounding Winston-Salem, NC
- Sedentary (engages in fewer than 30 minutes of moderate structured physical activity for at least 10 minutes at a time each week)
- Overweight or obese, as defined by a body mass index (BMI) greater than 25
- Fasting glucose level less than 140
- Documented evidence of an MI, PCTA, chronic stable angina, or cardiovascular surgery (coronary artery or valvular heart disease) within the 6 months prior to study entry or an ATP III diagnosis of the metabolic syndrome
Key exclusion criteria (12 listed)
- Diagnosis of bipolar depression or schizophrenia (defined as self-reported treatment for these conditions)
- Currently receiving lithium or neuroleptics
- Evidence of unstable angina, symptomatic congestive heart failure, or exercise-induced complex ventricular arrhythmias
- Resting blood pressure greater than 160/100 mmHg
- Diagnosis of any of the following: Parkinson's disease; chronic liver disease (cirrhosis, chronic hepatitis, etc.); systemic rheumatic condition (rheumatoid arthritis, psoriatic arthritis, Reiter's disease, systemic lupus erythematosus, etc.); end stage renal disease; or other systemic diseases or abnormal laboratory values which would preclude participants from safely participating in the protocol or impair their ability to complete the study
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 |
|---|---|---|
| ExerciseAlso: Physical activityIncrease Physical Activity to 150 min/wk | Behavioural | Exercise Only |
| Weight LossAlso: Diet modificationLose 7-10% of body weight and increase physical activity to 150 min/wk | Behavioural | Weight Loss |
| Health Education ControlAlso: Attention controlLectures on information relevant to successful aging | Behavioural | Health education control |
Primary outcome
400 meter walk
Time frame: Measured at 18 months
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 15 Aug 2018.
- Derived from this study: PubMed 22773225Brawley L, Rejeski WJ, Gaukstern JE, Ambrosius WT. Social cognitive changes following weight loss and physical activity interventions in obese, older adults in poor cardiovascular health. Ann Behav Med. 2012 Dec;44(3):353-64. doi: 10.1007/s12160-012-9390-5.
- Derived from this study: PubMed 21263080Rejeski WJ, Brubaker PH, Goff DC Jr, Bearon LB, McClelland JW, Perri MG, Ambrosius WT. Translating weight loss and physical activity programs into the community to preserve mobility in older, obese adults in poor cardiovascular health. Arch Intern Med. 2011 May 23;171(10):880-6. doi: 10.1001/archinternmed.2010.522. Epub 2011 Jan 24.
- Individual participant dataSharing planned: No
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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.
Walter Rejeski principal investigator
Wake Forest University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Weight Loss in people with Cardiovascular Diseases and Heart Diseases, run by Wake Forest University Health Sciences at 3 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 7 inclusion and 12 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 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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?
400 meter walk (time frame: Measured at 18 months). 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 NCT00119795, which also lists 2 linked publications.
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 15 Aug 2018.