Mode
Text Size
Log in / Sign up
N/A Completed N=35 Randomized Supportive Care

eHealth Weight Loss Program in African American Breast Cancer Survivors

Cancer Survivor · Stage IA Breast Cancer · Stage IB Breast Cancer · Stage IIA Breast Cancer
Source: ClinicalTrials.gov NCT02699983 ↗
Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcomePrimary: Recruitment Rate — 18; 17 Participants

Summary

This randomized pilot clinical trial studies how well a virtual weight loss program (SparkPeople) works in helping female African American breast cancer survivors maintain a healthy weight. Many patients with breast cancer are overweight or gain weight after diagnosis. SparkPeople is a free web-based weight loss program that features educational and motivational articles and videos, self-monitoring tools, incentives, social support communities (including discussion forums, teams, challenges, and expert blogs), and options for content to be delivered to members' email. It is a comprehensive program that includes advice on diet, physical activity, and behavioral strategies (such as self-monitoring diet and exercise), and emphasizes safe weight loss and receiving medical attention regularly when needed. A web-based program such as SparkPeople may help breast cancer survivors maintain a healthy weight, which may reduce the risk of cancer returning and patient fatigue, and improve patient quality of life.

Outcome Measures

OutcomeResultp-value
PRIMARY
Recruitment Rate
18; 17 —
PRIMARY
Retention Rate
17; 17 —
PRIMARY
Adherence to SparkPeople- Logged in
2.30; 1.14 —
PRIMARY
Adherence to SparkPeople- Logged Food
0.6; 0.71 —
PRIMARY
Acceptability of SparkPeople
3.53; 3.42 —
PRIMARY
Adherence to Fitbit
5.57; 5.61 —
PRIMARY
Acceptability of Fitbit
4.00; 4.00 —
SECONDARY
Change in Weight
-1.71; -2.53 —
SECONDARY
Change in Waist Circumference
-3.56; -0.84 —
SECONDARY
Change in Caloric Intake
-216.65; -173.06 —
SECONDARY
Change in Physical Activity
-107.07; -205.47 —
SECONDARY
Cardiopulmonary Fitness
26.64; 31.97 —
SECONDARY
Change in Quality of Life
-9.44; -4.65 —
SECONDARY
Self-efficacy, Eating Healthy Foods
5.59; -6.59 —
SECONDARY
Social Support for Healthy Nutrition
0.39; 0.11 —

Eligibility Criteria

Inclusion Criteria

  • Patients must have evidence of histologically confirmed breast cancer, stage 0, I, II or III, and be at least 2 years post diagnosis
  • Patient is self-identified as African-American
  • Patient is overweight or obese (body mass index [BMI] >= 25 kg/m^2)
  • Patient is able to understand and read English
  • Patient must have home internet or smartphone access
  • Patient must give informed consent for this new study

Exclusion Criteria

  • Patient has a serious medical condition (e.g., stroke, liver or renal failure, congestive heart failure, myocardial infarction or cardiac surgery in past year, angina pectoris) that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator
  • Patient has serious psychiatric condition (e.g., bipolar disorder, schizophrenia or other psychosis, bulimia or anorexia nervosa, suicide attempt within 6 months or current active suicidal ideation) that would compromise the patient's ability to complete the study, at the discretion of the investigator
  • Patient has severe disabilities limiting moderate physical activity, such as severe orthopedic conditions
  • Patient is planning major surgery within the next 6 months
  • Patient is taking medications or supplements for weight loss currently or within the past 3 months
  • Patient has successfully lost 5% of body weight in the previous 6 months or has had bariatric surgery
  • Patient is pregnant, breastfeeding, has given birth within the last 3 months or planning pregnancy within the next 12 months; if participant becomes pregnant during the course of the study, she will be removed from further participation
  • Patient is anticipating leaving the area within the next 12 months
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02699983). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

Back to search