ObesityPhase 1/2NCT01584596
Steps Ahead, Adapting Physical Activity Guidelines for the Lower Mississippi Delta Population
A Phase 1/2 study testing Adapted Dietary Guidelines and Adapted Physical Activity Guidelines in people with Obesity, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
The Lower Mississippi Delta (LMD) population is characterized by high levels of overweight and obesity, which are the result of long-term disruptions in energy imbalance where dietary energy intake has exceeded energy expenditure associated with physical activity. Read more about this study
- Who is it for?
- Ages 35 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Adapted Dietary Guidelines and Adapted Physical Activity Guidelines
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Aug 2013
- Phase
- Phase 1/2
- 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 35 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 35-64 years
- Body mass index (BMI) 25 to 34.9 kg/m2
- Physically capable of undertaking physical activity
- The capability and willingness to give written informed consent, to understand exclusion criteria, and to accept the randomized group assignment
Who cannot join
- Blood pressure greater than 159 mmHg systolic or 99 mmHg diastolic
- Total cholesterol greater than or equal to 240 mg/dl with LDL-C greater than or equal to 160 mg/dl or TG levels greater than or equal to 300 mg/dl
- Previously undiagnosed or uncontrolled Type 2 diabetes
- A past history and/or physical examination or laboratory findings of a medical condition including but not limited to chronic or recurrent cardiovascular, respiratory, gastrointestinal, neuromuscular, neurological, or psychiatric conditions.
- Musculoskeletal problems interfering with exercise. Immunodeficiency diseases or a positive HIV test.
- Malignancies in the past 5 years, with the exception of skin cancer therapeutically controlled.
Show all 13Show fewer
- Any other medical condition or disease that is life-threatening or that can interfere with or be aggravated by exercise
- Pregnant or breastfeeding or plans to become pregnant within the next 4 months.
- Has taken any form of weight loss medication or medications known to affect weight in the past 30 days.
- Have begun taking any new regular prescription medications within the last 3 months (a 3 month stable dose is allowed)
- Planning on starting any new form of medication within the next 4 months
- Being an athlete or highly and regularly physically active (defined as 20 minutes of vigorous activity 3 times per week or 30 minutes of moderate activity 5 times per week)
- Participants not providing adequate accelerometry data i.e. who have not worn the device during waking hours for a full 7 days will be excluded at Visit 3.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
The Lower Mississippi Delta (LMD) population is characterized by high levels of overweight and obesity, which are the result of long-term disruptions in energy imbalance where dietary energy intake has exceeded energy expenditure associated with physical activity. To address this issue, the overall goal of this project is to determine ways in which the U.S. Department of Health and Human Services and U.S. Department of Agriculture Dietary Guidelines for Americans (2005) physical activity recommendations can be effectively adapted for the LMD population. Phase I of this study was completed in early 2011.
Read the detailed description
During Phase I, we determined the feasibility of adapting physical activity recommendations by incorporating pedometers (step-counters) as self-monitoring tools within the context of an education program. Lessons learned from the feasibility study have been incorporated into the design of the current proposed Phase II program. This study will be an appropriately powered, randomized controlled effectiveness trial of physical activity and adapted dietary guidelines (DG) eating patterns to reduce unhealthy weight gain. The Steps Ahead study will use the step-based physical activity recommendations identified in Phase I.
Participants will be randomized and orientated into one of two groups. One group will be an adapted DG group who will receive education on the adapted DG guidelines. The second group will be an adapted DG plus physical activity group who will also receive the adapted DG guidelines education plus a physical activity intervention. The diet and physical activity recommendations have been developed to be used as low-intensity interventions in order to ensure maximal sustainability in the population. This intervention will be undertaken in East Baton Rouge parish, an area of the Delta region which contains communities and neighborhoods representative of the broader Delta region.
- Conditions
- Obesity
- Being tested
- Adapted Dietary Guidelines, Adapted Physical Activity Guidelines
- Keywords
- physical activity, dietary, adults, pedometer, education
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Dietary GuidelinesBehavioural
This group will receive dietary counseling to reduce their overall dietary food intake by 100 kcal/day, as prescribed by the dietary guidelines for the prevention of weight gain, and to follow an adapted eating pattern (to be determined from formative research in Phase I research).
The education sessions will be organized into two phases: an initial adoption phase and a subsequent adherence phase. During the adoption phase, participants will meet for one session per week for the first four weeks. During this session their interim weight will be recorded before they receive their session. During the adherence phase, participants will be contacted by telephone biweekly by a trained interventionist.
Adapted Physical Activity GuidelinesBehavioural
Also called Pedometer
The physical activity education sessions will be organized into two phases: an initial adoption phase and a subsequent adherence phase. The adoption phase will be for 1 hour and 45 minutes for the first 4 weeks with classes occurring once per week in conjunction with the DG education classes. During the adoption phase, participants monitor their own walking using pedometers and attend weekly group meetings to review the previous week's walking behaviors, discuss preferred strategies for success, and set personally relevant and incremental steps/day goals. During the adherence phase (the remaining 8 weeks), participants will continue with their self-monitoring and goal-setting (using their pedometers), with reduced contact with the study interventionists over the telephone (biweekly).
| Study group | Role | What they receive |
|---|---|---|
| Adapted Diet and Physical Activity | Experimental | Adapted diet and physical activity guidelines sessions Receives: Behavioral: Adapted Dietary Guidelines; Behavioral: Adapted Physical Activity Guidelines |
| Adapted Diet | Active comparator | Adapted dietary guidelines sessions Receives: Behavioral: Adapted Dietary Guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Body weight change
Measured: Week 0, 1, 2, 3 and 4 and week 12 (termination of intervention)
Secondary outcomes (1)
Moderate to Vigorous Physical Activity
Accelerometer measured moderate to vigocous physical activity levels
Measured: Week 0 and week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter T. Katzmarzyk, Pennington Biomedical Research Center
- Investigators
- Peter T Katzmarzyk, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01584596
- Sponsor's protocol ID
- PBRC 11028
- Status last verified
- Feb 2016
- First submitted
- 23 Apr 2012
- Last updated
- 5 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Harrington DM, Champagne CM, Broyles ST, Johnson WD, Tudor-Locke C, Katzmarzyk PT. Steps ahead: a randomized trial to reduce unhealthy weight gain in the Lower Mississippi Delta. Obesity (Silver Spring). 2014 May;22(5):E21-8. doi: 10.1002/oby.20684. Epub 2014 Jan 25.
PubMed 24376252Harrington DM, Champagne CM, Broyles ST, Johnson WD, Tudor-Locke C, Katzmarzyk PT. Cardiometabolic risk factor response to a lifestyle intervention: a randomized trial. Metab Syndr Relat Disord. 2015 Apr;13(3):125-31. doi: 10.1089/met.2014.0112. Epub 2015 Jan 8.
PubMed 25569324Barreira TV, Harrington DM, Schuna JM Jr, Tudor-Locke C, Katzmarzyk PT. Pattern changes in step count accumulation and peak cadence due to a physical activity intervention. J Sci Med Sport. 2016 Mar;19(3):227-231. doi: 10.1016/j.jsams.2015.01.008. Epub 2015 Feb 3.
PubMed 25687483
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Steps Ahead, Adapting Physical Activity Guidelines for the Lower Mississippi Delta Population
- ClinicalTrials.gov ID
- NCT01584596
- Acronym / sponsor ID
- PBRC 11028
- Conditions
- Obesity
- Keywords
- physical activity, dietary, adults, pedometer, education
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 25 Apr 2012 (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.
The Lower Mississippi Delta (LMD) population is characterized by high levels of overweight and obesity, which are the result of long-term disruptions in energy imbalance where dietary energy intake has exceeded energy expenditure associated with physical activity. To address this issue, the overall goal of this project is to determine ways in which the U.S. Department of Health and Human Services and U.S. Department of Agriculture Dietary Guidelines for Americans (2005) physical activity recommendations can be effectively adapted for the LMD population. Phase I of this study was completed in early 2011.
Detailed description
During Phase I, we determined the feasibility of adapting physical activity recommendations by incorporating pedometers (step-counters) as self-monitoring tools within the context of an education program. Lessons learned from the feasibility study have been incorporated into the design of the current proposed Phase II program. This study will be an appropriately powered, randomized controlled effectiveness trial of physical activity and adapted dietary guidelines (DG) eating patterns to reduce unhealthy weight gain. The Steps Ahead study will use the step-based physical activity recommendations identified in Phase I.
Participants will be randomized and orientated into one of two groups. One group will be an adapted DG group who will receive education on the adapted DG guidelines. The second group will be an adapted DG plus physical activity group who will also receive the adapted DG guidelines education plus a physical activity intervention. The diet and physical activity recommendations have been developed to be used as low-intensity interventions in order to ensure maximal sustainability in the population. This intervention will be undertaken in East Baton Rouge parish, an area of the Delta region which contains communities and neighborhoods representative of the broader Delta region.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adapted Diet and Physical Activity | Experimental | Behavioral: Adapted Dietary Guidelines, Behavioral: Adapted Physical Activity GuidelinesAdapted diet and physical activity guidelines sessions |
| Adapted Diet | Active comparator | Behavioral: Adapted Dietary GuidelinesAdapted dietary guidelines sessions |
Who may qualify
- Ages
- 35 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 35-64 years
- Body mass index (BMI) 25 to 34.9 kg/m2
- Physically capable of undertaking physical activity
- The capability and willingness to give written informed consent, to understand exclusion criteria, and to accept the randomized group assignment
Key exclusion criteria (13 listed)
- Blood pressure greater than 159 mmHg systolic or 99 mmHg diastolic
- Total cholesterol greater than or equal to 240 mg/dl with LDL-C greater than or equal to 160 mg/dl or TG levels greater than or equal to 300 mg/dl
- Previously undiagnosed or uncontrolled Type 2 diabetes
- A past history and/or physical examination or laboratory findings of a medical condition including but not limited to chronic or recurrent cardiovascular, respiratory, gastrointestinal, neuromuscular, neurological, or psychiatric conditions.
- Musculoskeletal problems interfering with exercise. Immunodeficiency diseases or a positive HIV test.
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 |
|---|---|---|
| Adapted Dietary GuidelinesThis group will receive dietary counseling to reduce their overall dietary food intake by 100 kcal/day, as prescribed by the dietary guidelines for the prevention of weight gain, and to follow an adapted eating pattern (to be determined from formative research in Phase I research). The education sessions will be organized into two phases: an initial adoption phase and a subsequent adherence phase. During the adoption phase, participants will meet for one session per week for the first four weeks. During this session their interim weight will be recorded before they receive their session. During the adherence phase, participants will be contacted by telephone biweekly by a trained interventionist. | Behavioural | Adapted Diet, Adapted Diet and Physical Activity |
| Adapted Physical Activity GuidelinesAlso: PedometerThe physical activity education sessions will be organized into two phases: an initial adoption phase and a subsequent adherence phase. The adoption phase will be for 1 hour and 45 minutes for the first 4 weeks with classes occurring once per week in conjunction with the DG education classes. During the adoption phase, participants monitor their own walking using pedometers and attend weekly group meetings to review the previous week's walking behaviors, discuss preferred strategies for success, and set personally relevant and incremental steps/day goals. During the adherence phase (the remaining 8 weeks), participants will continue with their self-monitoring and goal-setting (using their pedometers), with reduced contact with the study interventionists over the telephone (biweekly). | Behavioural | Adapted Diet and Physical Activity |
Primary outcome
Body weight
Time frame: Week 0, 1, 2, 3 and 4 and week 12 (termination of intervention)
Body weight change
1 secondary outcome
Moderate to Vigorous Physical Activity
Time frame: Week 0 and week 13
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 5 Feb 2016.
- Results publication: PubMed 24376252Harrington DM, Champagne CM, Broyles ST, Johnson WD, Tudor-Locke C, Katzmarzyk PT. Steps ahead: a randomized trial to reduce unhealthy weight gain in the Lower Mississippi Delta. Obesity (Silver Spring). 2014 May;22(5):E21-8. doi: 10.1002/oby.20684. Epub 2014 Jan 25.
- Results publication: PubMed 25569324Harrington DM, Champagne CM, Broyles ST, Johnson WD, Tudor-Locke C, Katzmarzyk PT. Cardiometabolic risk factor response to a lifestyle intervention: a randomized trial. Metab Syndr Relat Disord. 2015 Apr;13(3):125-31. doi: 10.1089/met.2014.0112. Epub 2015 Jan 8.
- Results publication: PubMed 25687483Barreira TV, Harrington DM, Schuna JM Jr, Tudor-Locke C, Katzmarzyk PT. Pattern changes in step count accumulation and peak cadence due to a physical activity intervention. J Sci Med Sport. 2016 Mar;19(3):227-231. doi: 10.1016/j.jsams.2015.01.008. Epub 2015 Feb 3.
- 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.
Peter T Katzmarzyk, PhD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Adapted Dietary Guidelines and Adapted Physical Activity Guidelines in people with Obesity, run by Pennington Biomedical Research Center 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 4 inclusion and 13 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 5 Feb 2016. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Body weight (time frame: Week 0, 1, 2, 3 and 4 and week 12 (termination 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 NCT01584596, which also lists 3 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 5 Feb 2016.