NCT03150381

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
369

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 12, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
Last Updated

May 16, 2018

Status Verified

May 1, 2018

Enrollment Period

5.9 years

First QC Date

May 10, 2017

Last Update Submit

May 14, 2018

Conditions

Weight LossCancer

Outcome Measures

Primary Outcomes (1)

  • Weight

    Measured weight (nearest kg)

    Baseline to 6 months

Secondary Outcomes (14)

  • Waist Circumference

    Baseline to 24 months

  • Lipids

    Baseline to 24 months

  • Blood Pressure

    Baseline to 24 months

  • Weight

    Baseline to 12 months

  • Weight

    Baseline to 24 months

  • +9 more secondary outcomes

Study Arms (3)

Weight Loss Only

ACTIVE COMPARATOR

Group-based behavioral weight loss intervention designed to reach clinically significant weight loss (\~5-10% of baseline weight).

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.

Behavioral: Weight Loss Plus

Control

ACTIVE COMPARATOR

Educational materials and optional participation in community-wide cancer awareness activities.

Behavioral: Control

Interventions

Weight Loss OnlyBEHAVIORAL

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 Only
Weight Loss PlusBEHAVIORAL

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 Plus
ControlBEHAVIORAL

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

Control

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Weight LossNeoplasms

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single Blind (Participant)
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 10, 2017

First Posted

May 12, 2017

Study Start

May 1, 2012

Primary Completion

March 31, 2018

Study Completion

March 31, 2018

Last Updated

May 16, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)