Daughters, dUdes, Mothers and othErs Fighting Cancer Together
- Conditions
- Overweight and ObesityCancer
- Interventions
- Behavioral: eHealth Intervention
- Registration Number
- NCT04132219
- Lead Sponsor
- University of Alabama at Birmingham
- Brief Summary
The purpose of this protocol is to conduct a 2-arm, single-blinded randomized controlled clinical trial (RCT) in which 56 dyads (defined as consisting of an overweight or obese cancer survivor of an obesity-related cancer and an overweight or obese "buddy" of his or her choosing) would be assigned either to a 6-month, diet- and exercise-based weight loss intervention delivered via an interactive website with tailored text messages, or to a 6-month wait-listed control group. The overall goals of the eHealth intervention are to reduce obesity and select circulating biomarkers (tumor necrosis factor alpha \[TNFα\], insulin, and insulin-like growth factor-1 \[IGF-1\]), as well as improve diet quality, physical activity, health-related quality of life (QoL), physical functioning and performance as compared to the control over the 6-month study period.
- Detailed Description
The specific aims of this protocol are to: 1) determine whether dyads (comprised of an overweight / obese cancer survivor and an overweight / obese buddy of his or her choosing) lose significantly more weight (kg) at 6-months when assigned to the eHealth intervention compared to a wait-listed control; 2) explore between-arm differences in score changes between baseline and 6-month follow-up for other key outcomes including measures of adiposity (e.g., waist circumference \[WC\] and body mass index \[BMI\]), blood pressure, diet quality, physical activity, health-related Quality of Life (QoL), physical functioning and performance; 3) Assess the impact of the intervention on select biomarkers associated with cancer risk and progression, e.g., tumor TNFα, insulin and IGF-1; and, 4) identify predictor variables associated with program efficacy, e.g., social support, self-efficacy, risk for depression, and dyad partner (spouse, relative, friend/neighbor).
Cancer survivors and their selected "buddies" who are interested in participating will be directed to a website that describes this study in detail. If interested, they will be asked to complete an online screener requiring information on race/ethnicity, gender, state of residence and eligibility criteria. Once interested participants are assessed for eligibility, consented and enrolled, they will be asked to complete online questionnaires that assess physical activity, dietary intake, health-related quality of life, risk for depression, self-efficacy, social support and barriers to diet resources. Finally, anthropometric measures, blood pressure, physical performance and circulating biomarkers will be collected in participants' homes by visiting study staff (whom the project manager will deploy after checking for a mutually convenient time for the 2-person dyad.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 112
- Adults age 18+ for whom at least one dyad member has been diagnosed and completed curative treatment for localized renal cancer, or loco-regional ovarian, colorectal, endometrial, or female breast cancer. (Loco-regional prostate cancer survivors are also eligible but could be on active surveillance).
- Diagnosed as overweight or obese (BMI >25 kg/m2.
- Low vegetable and fruit intake (<2.5 cups day).
- Low physical activity (<150 minutes per week).
- English-speaking and writing.
- Completed at least 5th grade.
- Uses the internet and owns a mobile phone.
- Diagnosed with uncontrolled chronic conditions (i.e., diabetes, blood pressure, CVD, etc)
- Diagnosed with a health conditions that precludes adherence to an unsupervised weight loss intervention (e.g., pregnancy, end-stage renal disease, etc).
- Instructed by a physician to limit physical activity AND have paralysis, dementia, blindness, unstable angina, untreated stage 3 hypertension, or recent history of heart attack, congestive heart failure or pulmonary conditions that required oxygen or hospitalization within 6 months.
- Diagnosed with other cancers (except non-malignant skin cancer), cancer recurrence or metastatic disease.
- Resides in a skilled nursing or assisted living facility.
- Resides more than 15 minute driving distance from dyad partner.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Delayed Intervention Group eHealth Intervention Participants assigned to the Delayed Intervention Group will receive a "Welcome Box" which on the outside is identical (and also is comparably weighted with bottled water) to that given to the Immediate Intervention group. This box would include: 1) Letters describing the project logistics and the important roles of each dyad member; and 2) monthly online study newsletters on topics unrelated to diet and exercise, but still of interest to cancer survivors and dyad members such as coping with stress, reducing exposure to radiation, sun safety, etc. to enhance retention and will be offered the opportunity to receive the online intervention after completing final 6-month assessments. Immediate Intervention Group eHealth Intervention Dyads randomized to the Immediate Intervention Group will receive a "Welcome Box" at completion of the baseline assessment. The Welcome Box will include two of each of the following: 1) Letters describing the project logistics and the important roles of each dyad member); 2) WiFi-enabled Scales (with instructions to weigh daily); 3) Portion Doctor ®Tableware (with instructions to use the portion plates at least once a day); 4) Fitbit® Inspire Activity Monitors (with instructions to share data with the dyad member and the study office); and 5) Instructions on how to create a secured account on the DUET website and instructions for logging on.
- Primary Outcome Measures
Name Time Method Body Weight 6 months Change in measured body weight
- Secondary Outcome Measures
Name Time Method EQ-5D-5L 6 months 6-item Likert scale assessment of Quality of Life
Duke OARS Co-Morbidity Index 6 months 43-item assessment of co-morbid conditions (multiple choice) (modified by removing 1 item)
Waist Circumference 6 months measured with a non-stretch tape
Physical Activity (self-reported) 6 months Godin Leisure Time Physical Activity Questionnaire (4-item survey) - individuals provide the number of minutes of vigorous, moderate and light physical activity per week. The minimum is 0 - theoretically, the maximum is 10,080 (the number of minutes in a week), then they are asked if this level of activity is "typical." The higher the number of minutes of totaled moderate + vigorous activity, the better.
Physical Activity (objective) 6 months Accelerometry (7-day assessment)
Diet Quality 6 months Two 24-hour dietary recalls
Physical Performance (endurance) 6 months 2-minute step test
Physical Performance (lower body strength) 6 months 30-second chair stand
Physical Performance (agility) 6 months 8' foot up and go
Physical Performance (gait speed) 6 months 8' walk
Physical Performance (Balance) 6 months Side-by-side, semi-tandem and tandem stances
Self-efficacy for calorically restricted diet 6 months Clark et al. survey (20 items). Respondents either affirm or deny that they can resist high fat, high calorie foods under a variety of situations. Individuals who have maximum willpower achieve the top score of 20, whereas those with lesser willpower score lower (the minimum score is zero)
Circulating CRP 6 months assays on dried blood spot eluents
Self-efficacy for increased physical activity 6 months Sallis et al. survey (6 items in total). Respondents rate themselves on each item from 0 to 100% on their level of confidence. The higher the total score (maximum of 100%) the better (Minimum 0%).
Social support for calorically restricted diet 6 months Sallis et al. instrument (4 items). Respondents rate the level of support they obtain to follow a healthy, low calorie diet on a 5-point scale ranging from ("never"= 0 to "everyday" = 4. Individuals who have maximum support achieve the top score of 16, whereas those with lesser support score lower (the minimum score is zero)
Social support for increased physical activity 6 months Sallis et al. instrument (4 items in total) Respondents rate the level of support they obtain to increase their level of physical activity on a 5-point scale ranging from ("never"= 0 to "everyday" = 4. Individuals who have maximum support achieve the top score of 16, whereas those with lesser support score lower (the minimum score is zero)
Barriers for increased physical activity 6 months (15 items in total) Respondents either affirm or deny common barriers to exercise. Individuals who report more barriers achieve the top score of 21, whereas those with fewer barriers score lower (the minimum score is zero) and that is considered better.
Circulating insulin 6 months assays on dried blood spot eluents
Circulating glucose 6 months assays on dried blood spot eluents
Circulating IL-6 6 months assays on dried blood spot eluents
Circulating Leptin 6 months assays on dried blood spot eluents
PROMIS v.1.2 GLOBAL HEALTH 6 months 10-item Likert scale assessment of Quality of Life
Circulating Total Cholesterol 6 months assays on dried blood spot eluents
Circulating HDL Cholesterol 6 months assays on dried blood spot eluents
Circulating Tryglycerides 6 months assays on dried blood spot eluents
Circulating Adiponectin 6 months assays on dried blood spot eluents
HEALTH / E-HEALTH LITERACY SCALE (NORMAN 2006) 6 months 7-item scale to assess health and e-health literacy. Two items were added from eHEALS to understand consumer's interest in using eHealth in general.
Barriers to Eating a Healthy Low Calorie Diet 6 months (10 items) Respondents either affirm or deny common barriers to low calorie diet.
PROMIS Emotional Distress: Depression - Short Form 8a 6 months (8 items) Likert scale assessment of depression
Smoking status 6 months 2 items that ask whether respondent has ever smoked \>100 cigarettes and current smoking status.
Trial Locations
- Locations (1)
UAB School of Health Professions, Department of Nutrition Sciences
🇺🇸Birmingham, Alabama, United States