Weight LossDSNCARESNCT03150381
Promoting Weight-Loss in African American Cancer Survivors in the Deep South
A study testing Weight Loss Only and Weight Loss Plus in people with Weight Loss and Cancer, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This study tests evidence-based strategies for weight loss among overweight and obesity cancer survivors and family members in rural Alabama. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Cancer
- 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
- 369 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2012to 31 Mar 2018
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- African American breast, colon, or prostate cancer survivor (Index Participant)
- Family member (support person) of African American breast, colon, or prostate cancer survivor (Family Member Participant)
- Live, work, or attend school 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)
- medicated or poorly controlled diabetes (glucose > 126) Cardiovascular event in the preceding 12 months
- History of gastric bypass or bariatric surgery
- History of psychiatric hospitalization in past 2 years
- 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
This study tests evidence-based strategies for weight loss among overweight and obesity cancer survivors and family members in rural Alabama.
Read the detailed description
This is a 3-arm cluster randomized controlled study that compares a trained lay provided weight loss program vs. the same program plus community-based weight management strategies vs. general cancer prevention education on weight loss and other clinical outcomes (primary outcomes) and healthy behaviors, and psychosocial functioning (secondary outcomes).
- Conditions
- Weight Loss, Cancer
- Being tested
- Weight Loss Only, Weight Loss Plus, Control
- Medical subject headings
- Weight Loss, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight Loss OnlyBehavioural
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)
Weight Loss PlusBehavioural
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.
ControlBehavioural
Participants receive quarterly newsletters containing generic cancer prevention messages and participate in community-wide cancer awareness educational sessions.
| Study group | Role | What they receive |
|---|---|---|
| Weight Loss Only | Active comparator | Group-based behavioral weight loss intervention designed to reach clinically significant weight loss (~5-10% of baseline weight). Receives: Behavioral: Weight Loss Only |
| Weight Loss Plus | Experimental | Group-based behavioral weight loss intervention designed to reach clinically significant weight loss (~5-10% of baseline weight) plus community-level strategies to support healthy weight. Strategies are based on CDC's recommended community strategies and are developed by local contractors. They include expanded farmers markets/gardens, improvement to walking trails, etc. Receives: Behavioral: Weight Loss Plus |
| Control | Active comparator | Educational materials and optional participation in community-wide cancer awareness activities. Receives: Behavioral: Control |
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 (14)
Waist Circumference
Measured circumference (nearest cm)
Measured: Baseline to 24 months
Lipids
Measured total cholesterol, triglycerides, HDL, LDL, ratio (mg/dL)
Measured: Baseline to 24 months
Blood Pressure
Measured blood pressure (mmHG) - systolic and diastolic
Measured: Baseline to 24 months
Weight
Measured weight (nearest kg)
Measured: Baseline to 12 months
Weight
Measured weight (nearest kg)
Measured: Baseline to 24 months
Social Support for Diet and Exercise Behaviors
self report measure of social support (family, friend) in performing diet and exercise behaviors
Measured: Baseline to 6 months
Social Support for Diet and Exercise Behaviors
self report measure of social support (family, friend) in performing diet and exercise behaviors
Measured: Baseline to 12 months
Social Support for Diet and Exercise Behaviors
self report measure of social support (family, friend) in performing diet and exercise behaviors
Measured: Baseline to 24 months
Self Efficacy for Diet and Exercise Behaviors
self report measure of confidence in performing diet and exercise behaviors
Measured: Baseline to 6 months
Self Efficacy for Diet and Exercise Behaviors
self report measure of confidence in performing diet and exercise behaviors
Measured: Baseline to 12 months
Self Efficacy for Diet and Exercise Behaviors
self report measure of confidence in performing diet and exercise behaviors
Measured: Baseline to 24 months
Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24)
self report measure of dietary intake
Measured: Baseline to 6 months
Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24)
self report measure of dietary intake
Measured: Baseline to 12 months
Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24)
self report measure of dietary intake
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 posted12 May 2017
- Study start1 May 2012
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 369 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monica L Baskin, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03150381
- Sponsor's protocol ID
- X120329018
- Acronym
- DSNCARES
- Status last verified
- May 2018
- First submitted
- 10 May 2017
- Last updated
- 16 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Weight-Loss in African American Cancer Survivors in the Deep South
- ClinicalTrials.gov ID
- NCT03150381
- Acronym / sponsor ID
- DSNCARES / X120329018
- Conditions
- Weight Loss, Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 369 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 May 2012 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 12 May 2017 (actual)
- 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 tests evidence-based strategies for weight loss among overweight and obesity cancer survivors and family members in rural Alabama.
Detailed description
This is a 3-arm cluster randomized controlled study that compares a trained lay provided weight loss program vs. the same program plus community-based weight management strategies vs. general cancer prevention education on weight loss and other clinical outcomes (primary outcomes) and healthy behaviors, and psychosocial functioning (secondary outcomes).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Weight Loss Only | Active comparator | Behavioral: Weight Loss OnlyGroup-based behavioral weight loss intervention designed to reach clinically significant weight loss (~5-10% of baseline weight). |
| Weight Loss Plus | Experimental | Behavioral: Weight Loss PlusGroup-based behavioral weight loss intervention designed to reach clinically significant weight loss (~5-10% of baseline weight) plus community-level strategies to support healthy weight. Strategies are based on CDC's recommended community strategies and are developed by local contractors. They include expanded farmers markets/gardens, improvement to walking trails, etc. |
| Control | Active comparator | Behavioral: ControlEducational materials and optional participation in community-wide cancer awareness activities. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- African American breast, colon, or prostate cancer survivor (Index Participant)
- Family member (support person) of African American breast, colon, or prostate cancer survivor (Family Member Participant)
- Live, work, or attend school in target county
- BMI >= 25 kg/m2
Key exclusion criteria (8 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)
- medicated or poorly controlled diabetes (glucose > 126) Cardiovascular event in the preceding 12 months
- History of gastric bypass or bariatric 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 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) | Behavioural | Weight Loss Only |
| Weight Loss PlusParticipants 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 Plus |
| ControlParticipants receive quarterly newsletters containing generic cancer prevention messages and participate in community-wide cancer awareness educational sessions. | Behavioural | Control |
Primary outcome
Weight
Time frame: Baseline to 6 months
Measured weight (nearest kg)
14 secondary outcomes
Waist Circumference
Time frame: Baseline to 24 months
Lipids
Time frame: Baseline to 24 months
Blood Pressure
Time frame: Baseline to 24 months
Weight
Time frame: Baseline to 12 months
Weight
Time frame: Baseline to 24 months
Social Support for Diet and Exercise Behaviors
Time frame: Baseline to 6 months
Social Support for Diet and Exercise Behaviors
Time frame: Baseline to 12 months
Social Support for Diet and Exercise Behaviors
Time frame: Baseline to 24 months
Self Efficacy for Diet and Exercise Behaviors
Time frame: Baseline to 6 months
Self Efficacy for Diet and Exercise Behaviors
Time frame: Baseline to 12 months
Self Efficacy for Diet and Exercise Behaviors
Time frame: Baseline to 24 months
Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24)
Time frame: Baseline to 6 months
Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24)
Time frame: Baseline to 12 months
Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24)
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 16 May 2018.
- Individual participant dataSharing planned: No
Related trials for Weight Loss
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
RecruitingPhase 1/2
Phase 1/2 Study of DS010 in Advanced Cancer Patients With Cachexia
Cancer, Cachexia
Active, not recruitingPhase 3
AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight
Diabetes Mellitus, Overweight
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 and Cancer, 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 4 inclusion and 8 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 16 May 2018. 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 16 May 2018.