Weight Loss Counseling for African American Women Who Are Breast Cancer Survivors
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | March 28, 2009 | ||||
| Last Updated Date | April 25, 2013 | ||||
| Start Date ICMJE | May 2004 | ||||
| Primary Completion Date | October 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Weight change [ Time Frame: 18 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Weight change [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00872677 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Weight Loss Counseling for African American Women Who Are Breast Cancer Survivors | ||||
| Official Title ICMJE | A Culturally-Tailored Weight Loss Program | ||||
| Brief Summary | RATIONALE: A culturally sensitive weight loss program for obese African American breast cancer survivors may be more effective than a standard weight loss program in helping women lose weight. PURPOSE: This randomized clinical trial is studying personalized weight loss counseling to see how well it works in African American women who are breast cancer survivors. |
||||
| Detailed Description | OBJECTIVES:
OUTLINE: This is a randomized study. Participants are randomized to 1 of 2 intervention groups.
|
||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Two groups to participate: Group 1: Dietitian led counseling and Weight Watchers groups for 18 months Group 2: Dietitian led counseling and Weight Watchers groups for 18 months with Spirituality counseling from 6 to 18 months. |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE |
|
||||
| Study Group/Cohort (s) |
|
||||
| Publications * | Djuric Z, Mirasolo J, Kimbrough L, Brown DR, Heilbrun LK, Canar L, Venkatranamamoorthy R, Simon MS. A pilot trial of spirituality counseling for weight loss maintenance in African American breast cancer survivors. J Natl Med Assoc. 2009 Jun;101(6):552-64. | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 31 | ||||
| Completion Date | November 2008 | ||||
| Primary Completion Date | October 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
|
||||
| Gender | Female | ||||
| Ages | 18 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00872677 | ||||
| Other Study ID Numbers ICMJE | CDR0000612147, 013003B3E | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Barbara Ann Karmanos Cancer Institute | ||||
| Study Sponsor ICMJE | Barbara Ann Karmanos Cancer Institute | ||||
| Collaborators ICMJE |
|
||||
| Investigators ICMJE |
|
||||
| Information Provided By | Barbara Ann Karmanos Cancer Institute | ||||
| Verification Date | April 2013 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||