Weight LossJTBHNCT02938312
Journey to Better Health
A study testing Weight Loss Only and Weight Loss Plus in people with Weight Loss, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This study is being conducted in 8 rural counties in Alabama and Mississippi (4 per state). Approximately 400 overweight or obese African American women living in the selected counties will participate in a 2-year weight loss study. Read more about this study
- Who is it for?
- Ages 30 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Weight Loss
- What is being tested?
- Weight Loss Only and Weight Loss Plus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 409 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Aug 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- African American female
- Live or work in target county
- BMI >= 25 kg/m2
Who cannot join
- Pregnant or planning to become pregnant in the next year
- Known major medical or psychological condition known to influence body weight
- Uncontrolled hypertension (BP > 160 mmHg systolic or >100 mmHg diastolic)
- Cardiovascular event in the preceding 12 months
- History of gastric bypass surgery
- History of psychiatric hospitalization in past 2 years
Show all 9Show fewer
- History of substance abuse or eating disorder
- Any other condition by which a medical professional has suggested diet modification
- Physical activity and/or weight reduction would be contraindicated
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Deep South Network for Cancer Control - Healthier Weight Among African American Women
This study is being conducted in 8 rural counties in Alabama and Mississippi (4 per state). Approximately 400 overweight or obese African American women living in the selected counties will participate in a 2-year weight loss study.
Read the detailed description
Using a cluster-randomized study design, 400 overweight or obese African American women living in 8 rural counties in Alabama and Mississippi associated with the Deep South Network for Cancer Control will be assigned to either a weight loss only or weight loss plus community strategies condition for 2 years.
Weight Loss Only condition: In year 1, participants will attend weekly in-person group sessions (1.5 hours each) aimed at behavioral changes for weight loss (diet and physical activity) for 6 months followed by twice a month meetings for 3 months, then monthly meetings for 3 months. In year 2, monthly phone calls will be used to encourage continued behavior change or weight maintenance. In-person group meetings will be facilitated by a trained lay staff and community health advisors. Monthly phone calls will be conducted by the community health advisor.
Weight Loss Plus Community Strategies condition: Participants will receive the same weight loss program as the Weight Loss Only condition. In addition, a community-based organization or other non-profit group in the targeted community will receive funds and technical assistance to implement community-wide efforts to increase access to healthy affordable food and safe and convenient opportunities for physical activity (e.g., increase farmer's markets, develop walking trails).
Over the course of the study, participants will complete four full assessments to include measurement of height and weight (to calculate BMI), waist circumference, blood pressure, finger-stick blood draw for lipid and glucose testing, dietary recall, and questionnaires concerning participation in physical activity, self-efficacy for eating and exercise behaviors, depressive symptoms, perceived stress, social support, and demographic information (e.g., age, marital status, education, employment, household income).
- Conditions
- Weight Loss
- Being tested
- Weight Loss Only, Weight Loss Plus
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight Loss OnlyBehavioural
Participants will attend in-person weekly sessions (about 1.5 hours each) for 6 months and then twice a month for 3 months and monthly for 3 months. Sessions focus on behavioral techniques supporting healthy diet (including calorie restriction for weight loss) and achieving recommended amounts of physical activity per week. During 1-year weight loss maintenance, participants receive monthly motivational phone calls.
Weight Loss PlusBehavioural
Participants attend in-person meetings as described above. This condition also includes community-wide strategies to increase access to healthy affordable food and safe opportunities for physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Weight Loss Only | Active comparator | 24- month weight loss program (year 1: weekly in-person meetings for 6 months, followed by 2 meetings per month for 3 months, then monthly for 3 months; year 2: monthly phone calls) Receives: Behavioral: Weight Loss Only |
| Weight Loss Plus | Experimental | Same intervention as "Weight Loss Only" but includes community-wide interventions to increase access to healthy affordable food and opportunities for safe and convenient physical activity Receives: Behavioral: Weight Loss Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Measured weight (nearest kg)
Measured: baseline to 6-months
Secondary outcomes (17)
Waist Circumference
Measured circumference (nearest cm)
Measured: baseline to 6-months
Blood Pressure
Measured blood pressure (mmHG) - systolic and diastolic
Measured: baseline to 6-months
Lipids
Measured lipids - total cholesterol (mg/dL), Triglycerides (mg/dL), HDL, LDL, ratio
Measured: baseline to 6-months
Weight
Measured weight (nearest kg)
Measured: baseline to 12-months
Weight
Measured weight (nearest kg)
Measured: baseline to 24-months
Social Support for Healthy Eating and Exercise
Self-report questionnaire about perceived level of family and friend support for healthy eating and exercise. Composite and subscale scores are calculated.
Measured: baseline to 6-months
Social Support for Healthy Eating and Exercise
Self-report questionnaire about perceived level of family and friend support for healthy eating and exercise. Composite and subscale scores are calculated.
Measured: baseline to 12-months
Social Support Healthy Eating and Exercise
Self-report questionnaire about perceived level of family and friend support for healthy eating and exercise. Composite and subscale scores are calculated.
Measured: baseline to 24-months
Self Efficacy for Healthy Eating and Exercise
Self-report questionnaire about confidence in ability to eat healthy and exercise. Composite and subscale scores are calculated.
Measured: baseline to 6-months
Self Efficacy for Healthy Eating and Exercise
Self-report
Measured: baseline to 12-months
Self Efficacy for Healthy Eating and Exercise
Self-report questionnaire about confidence in ability to eat healthy and exercise. Composite and subscale scores are calculated.
Measured: baseline to 24-months
Dietary Intake
24 hour recall
Measured: baseline to 6-months
Dietary Intake
24 hour recall
Measured: baseline to 12-months
Dietary Intake
24 hour recall
Measured: baseline to 24-months
Perceived Stress Scale
Self-report questionnaire about frequency of select stressful events. Composite score is calculated based on responses.
Measured: baseline to 6-months
Perceived Stress Scale
Self-report questionnaire about frequency of select stressful events. Composite score is calculated based on responses.
Measured: baseline to 12-months
Perceived Stress Scale
Self-report questionnaire about frequency of select stressful events. Composite score is calculated based on responses.
Measured: baseline to 24-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study startAug 2010
- Primary completionApr 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 409 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Monica L Baskin, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02938312
- Sponsor's protocol ID
- F100708003
- Other IDs
- 1U54CA153719
- Acronym
- JTBH
- Status last verified
- Oct 2016
- First submitted
- 17 Oct 2016
- Last updated
- 24 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep South Network for Cancer Control - Healthier Weight Among African American Women
- ClinicalTrials.gov ID
- NCT02938312
- Acronym / sponsor ID
- JTBH / F100708003
- Conditions
- Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 409 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2010
- Primary completion
- Apr 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 19 Oct 2016 (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.
This study is being conducted in 8 rural counties in Alabama and Mississippi (4 per state). Approximately 400 overweight or obese African American women living in the selected counties will participate in a 2-year weight loss study.
Detailed description
Using a cluster-randomized study design, 400 overweight or obese African American women living in 8 rural counties in Alabama and Mississippi associated with the Deep South Network for Cancer Control will be assigned to either a weight loss only or weight loss plus community strategies condition for 2 years.
Weight Loss Only condition: In year 1, participants will attend weekly in-person group sessions (1.5 hours each) aimed at behavioral changes for weight loss (diet and physical activity) for 6 months followed by twice a month meetings for 3 months, then monthly meetings for 3 months. In year 2, monthly phone calls will be used to encourage continued behavior change or weight maintenance. In-person group meetings will be facilitated by a trained lay staff and community health advisors. Monthly phone calls will be conducted by the community health advisor.
Weight Loss Plus Community Strategies condition: Participants will receive the same weight loss program as the Weight Loss Only condition. In addition, a community-based organization or other non-profit group in the targeted community will receive funds and technical assistance to implement community-wide efforts to increase access to healthy affordable food and safe and convenient opportunities for physical activity (e.g., increase farmer's markets, develop walking trails).
Over the course of the study, participants will complete four full assessments to include measurement of height and weight (to calculate BMI), waist circumference, blood pressure, finger-stick blood draw for lipid and glucose testing, dietary recall, and questionnaires concerning participation in physical activity, self-efficacy for eating and exercise behaviors, depressive symptoms, perceived stress, social support, and demographic information (e.g., age, marital status, education, employment, household income).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weight Loss Only | Active comparator | Behavioral: Weight Loss Only24- month weight loss program (year 1: weekly in-person meetings for 6 months, followed by 2 meetings per month for 3 months, then monthly for 3 months; year 2: monthly phone calls) |
| Weight Loss Plus | Experimental | Behavioral: Weight Loss PlusSame intervention as "Weight Loss Only" but includes community-wide interventions to increase access to healthy affordable food and opportunities for safe and convenient physical activity |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- African American female
- Live or work in target county
- BMI >= 25 kg/m2
Key exclusion criteria (9 listed)
- Pregnant or planning to become pregnant in the next year
- Known major medical or psychological condition known to influence body weight
- Uncontrolled hypertension (BP > 160 mmHg systolic or >100 mmHg diastolic)
- Cardiovascular event in the preceding 12 months
- History of gastric bypass surgery
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 |
|---|---|---|
| Weight Loss OnlyParticipants will attend in-person weekly sessions (about 1.5 hours each) for 6 months and then twice a month for 3 months and monthly for 3 months. Sessions focus on behavioral techniques supporting healthy diet (including calorie restriction for weight loss) and achieving recommended amounts of physical activity per week. During 1-year weight loss maintenance, participants receive monthly motivational phone calls. | Behavioural | Weight Loss Only |
| Weight Loss PlusParticipants attend in-person meetings as described above. This condition also includes community-wide strategies to increase access to healthy affordable food and safe opportunities for physical activity. | Behavioural | Weight Loss Plus |
Primary outcome
Weight
Time frame: baseline to 6-months
Measured weight (nearest kg)
17 secondary outcomes
Waist Circumference
Time frame: baseline to 6-months
Blood Pressure
Time frame: baseline to 6-months
Lipids
Time frame: baseline to 6-months
Weight
Time frame: baseline to 12-months
Weight
Time frame: baseline to 24-months
Social Support for Healthy Eating and Exercise
Time frame: baseline to 6-months
Social Support for Healthy Eating and Exercise
Time frame: baseline to 12-months
Social Support Healthy Eating and Exercise
Time frame: baseline to 24-months
Self Efficacy for Healthy Eating and Exercise
Time frame: baseline to 6-months
Self Efficacy for Healthy Eating and Exercise
Time frame: baseline to 12-months
Self Efficacy for Healthy Eating and Exercise
Time frame: baseline to 24-months
Dietary Intake
Time frame: baseline to 6-months
Dietary Intake
Time frame: baseline to 12-months
Dietary Intake
Time frame: baseline to 24-months
Perceived Stress Scale
Time frame: baseline to 6-months
Perceived Stress Scale
Time frame: baseline to 12-months
Perceived Stress Scale
Time frame: baseline to 24-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 24 Oct 2016.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight Loss Only and Weight Loss Plus in people with Weight Loss, run by University of Alabama at Birmingham 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 3 inclusion and 9 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 24 Oct 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.
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?
Weight (time frame: baseline to 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 24 Oct 2016.