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Completed

NCT Number: NCT03150381

Promoting Weight-Loss in African American Cancer Survivors in the Deep South

This study tests evidence-based strategies for weight loss among overweight and obesity cancer survivors and family members in rural Alabama.

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Key information

Conditions

Weight Loss Body Weight Body Weight Changes Cancer Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Weight Loss Only

Behavioral

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 Plus

Behavioral

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.

Control

Behavioral

Participants receive quarterly newsletters containing generic cancer prevention messages and participate in community-wide cancer awareness educational sessions.

Primary outcomes

  1. Weight

    Time frame: Baseline to 6 months

    Measured weight (nearest kg)

Secondary outcomes

  1. Waist Circumference

    Time frame: Baseline to 24 months

    Measured circumference (nearest cm)

  2. Lipids

    Time frame: Baseline to 24 months

    Measured total cholesterol, triglycerides, HDL, LDL, ratio (mg/dL)

  3. Blood Pressure

    Time frame: Baseline to 24 months

    Measured blood pressure (mmHG) - systolic and diastolic

  4. Weight

    Time frame: Baseline to 12 months

    Measured weight (nearest kg)

  5. Weight

    Time frame: Baseline to 24 months

    Measured weight (nearest kg)

  6. Social Support for Diet and Exercise Behaviors

    Time frame: Baseline to 6 months

    self report measure of social support (family, friend) in performing diet and exercise behaviors

  7. Social Support for Diet and Exercise Behaviors

    Time frame: Baseline to 12 months

    self report measure of social support (family, friend) in performing diet and exercise behaviors

  8. Social Support for Diet and Exercise Behaviors

    Time frame: Baseline to 24 months

    self report measure of social support (family, friend) in performing diet and exercise behaviors

  9. Self Efficacy for Diet and Exercise Behaviors

    Time frame: Baseline to 6 months

    self report measure of confidence in performing diet and exercise behaviors

  10. Self Efficacy for Diet and Exercise Behaviors

    Time frame: Baseline to 12 months

    self report measure of confidence in performing diet and exercise behaviors

  11. Self Efficacy for Diet and Exercise Behaviors

    Time frame: Baseline to 24 months

    self report measure of confidence in performing diet and exercise behaviors

  12. Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24)

    Time frame: Baseline to 6 months

    self report measure of dietary intake

  13. Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24)

    Time frame: Baseline to 12 months

    self report measure of dietary intake

  14. Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24)

    Time frame: Baseline to 24 months

    self report measure of dietary intake

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Acronym: DSNCARES

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
May 12, 2017
Registry last updated
May 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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