CancerDUETNCT04132219
Daughters, dUdes, Mothers and othErs Fighting Cancer Together
A study testing eHealth Intervention in people with Cancer and Overweight and Obesity, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Overweight and Obesity
- What is being tested?
- eHealth Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2020to 15 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UAB School of Health Professions, Department of Nutrition Sciences
Birmingham, Alabama, 35294
About this study
Official title: Daughters, (dUdes), Mothers and othErs Fighting Cancer Together
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.
Read the 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.
- Conditions
- Cancer, Overweight and Obesity
- Being tested
- eHealth Intervention
- Keywords
- cancer survivor, overweight, obesity
- Medical subject headings
- Neoplasms, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eHealth InterventionBehavioural
Every week, each dyad member will receive a tailored text message that provides a new fun fact or that encourages them to log-on to the website to access findings of new research and how the results might apply to them. They will be directed to specific pages in the Web-based program and asked to select strategies from a list that they will practice during the upcoming week. Graphic displays of their progress will be provided along with SCT-based feedback. They will be directed to the website to record their behavioral goals for the upcoming week. Tips also will be provided for effective communication to enhance couple efficacy. All usage will be tracked to assess adherence.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Intervention Group | Experimental | 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. Receives: Behavioral: eHealth Intervention |
| Delayed Intervention Group | Other | 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. Receives: Behavioral: eHealth Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
Change in measured body weight
Measured: baseline
Body Weight
Change in measured body weight
Measured: 6 months
Secondary outcomes (73)
Waist Circumference
measured with a non-stretch tape
Measured: baseline
Waist Circumference
measured with a non-stretch tape
Measured: 6 months
Physical Activity (self-reported)
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.
Measured: Baseline
Physical Activity (self-reported)
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.
Measured: 3 months
Physical Activity (self-reported)
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.
Measured: 6 months
Physical Activity (objective)
Accelerometry (7-day assessment)
Measured: baseline
Physical Activity (objective)
Accelerometry (7-day assessment)
Measured: 6 months
Diet Quality
Two 24-hour dietary recalls
Measured: baseline
Diet Quality
Two 24-hour dietary recalls
Measured: 6 months
Physical Performance (endurance)
2-minute step test
Measured: Baseline
Physical Performance (endurance)
2-minute step test
Measured: 6 months
Physical Performance (lower body strength)
30-second chair stand
Measured: Baseline
Physical Performance (lower body strength)
30-second chair stand
Measured: 6 months
Physical Performance (agility)
8' foot up and go
Measured: Baseline
Physical Performance (agility)
8' foot up and go
Measured: 6 months
Physical Performance (gait speed)
8' walk
Measured: baseline
Physical Performance (gait speed)
8' walk
Measured: 6 months
Physical Performance (Balance)
Side-by-side, semi-tandem and tandem stances
Measured: baseline
Physical Performance (Balance)
Side-by-side, semi-tandem and tandem stances
Measured: 6 months
Self-efficacy for calorically restricted diet
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)
Measured: baseline
Self-efficacy for calorically restricted diet
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)
Measured: 3 months
Self-efficacy for calorically restricted diet
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)
Measured: 6 months
Self-efficacy for increased physical activity
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%).
Measured: baseline
Self-efficacy for increased physical activity
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%).
Measured: 3 months
Self-efficacy for increased physical activity
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%).
Measured: 6 months
Social support for calorically restricted diet
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)
Measured: baseline
Social support for increased physical activity
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)
Measured: baseline
Social support for calorically restricted diet
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)
Measured: 3 months
Social support for increased physical activity
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)
Measured: 3 months
Social support for calorically restricted diet
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)
Measured: 6 months
Social support for increased physical activity
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)
Measured: 6 months
Barriers for increased physical activity
(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.
Measured: baseline
Barriers for increased physical activity
(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.
Measured: 3 months
Barriers for increased physical activity
(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.
Measured: 6 months
Circulating insulin
assays on dried blood spot eluents
Measured: baseline
Circulating insulin
assays on dried blood spot eluents
Measured: 6 months
Circulating glucose
assays on dried blood spot eluents
Measured: baseline
Circulating glucose
assays on dried blood spot eluents
Measured: 6 months
Circulating IL-6
assays on dried blood spot eluents
Measured: baseline
Circulating IL-6
assays on dried blood spot eluents
Measured: 6 months
Circulating CRP
assays on dried blood spot eluents
Measured: baseline
Circulating CRP
assays on dried blood spot eluents
Measured: 6 months
Circulating Total Cholesterol
assays on dried blood spot eluents
Measured: baseline
Circulating Total Cholesterol
assays on dried blood spot eluents
Measured: 6 months
Circulating HDL Cholesterol
assays on dried blood spot eluents
Measured: baseline
Circulating HDL Cholesterol
assays on dried blood spot eluents
Measured: 6 months
Circulating Tryglycerides
assays on dried blood spot eluents
Measured: baseline
Circulating Tryglycerides
assays on dried blood spot eluents
Measured: 6 months
Circulating Adiponectin
assays on dried blood spot eluents
Measured: baseline
Circulating Adiponectin
assays on dried blood spot eluents
Measured: 6 months
Circulating Leptin
assays on dried blood spot eluents
Measured: baseline
Circulating Leptin
assays on dried blood spot eluents
Measured: 6 months
Duke OARS Co-Morbidity Index
43-item assessment of co-morbid conditions (multiple choice) (modified by removing 1 item)
Measured: baseline
Duke OARS Co-Morbidity Index
43-item assessment of co-morbid conditions (multiple choice) (modified by removing 1 item)
Measured: 3 months
Duke OARS Co-Morbidity Index
43-item assessment of co-morbid conditions (multiple choice) (modified by removing 1 item)
Measured: 6 months
PROMIS v.1.2 GLOBAL HEALTH
10-item Likert scale assessment of Quality of Life
Measured: Baseline
PROMIS v.1.2 GLOBAL HEALTH
10-item Likert scale assessment of Quality of Life
Measured: 3 months
PROMIS v.1.2 GLOBAL HEALTH
10-item Likert scale assessment of Quality of Life
Measured: 6 months
EQ-5D-5L
6-item Likert scale assessment of Quality of Life
Measured: Baseline
EQ-5D-5L
6-item Likert scale assessment of Quality of Life
Measured: 3 months
EQ-5D-5L
6-item Likert scale assessment of Quality of Life
Measured: 6 months
HEALTH / E-HEALTH LITERACY SCALE (NORMAN 2006)
7-item scale to assess e-health literacy. Two items were added from eHEALS to understand consumer's interest in using eHealth in general.
Measured: Baseline
HEALTH / E-HEALTH LITERACY SCALE (NORMAN 2006)
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.
Measured: 3 months
HEALTH / E-HEALTH LITERACY SCALE (NORMAN 2006)
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.
Measured: 6 months
Barriers to Eating a Healthy Low Calorie Diet
(10 items) Respondents either affirm or deny common barriers to low calorie diet.
Measured: Baseline
Barriers to Eating a Healthy Low Calorie Diet
(10 items) Respondents either affirm or deny common barriers to low calorie diet.
Measured: 3 months
Barriers to Eating a Healthy Low Calorie Diet
(10 items) Respondents either affirm or deny common barriers to low calorie diet.
Measured: 6 months
PROMIS Emotional Distress: Depression - Short Form 8a
(8 items) Likert scale assessment of depression
Measured: Baseline
PROMIS Emotional Distress: Depression - Short Form 8a
(8 items) Likert scale assessment of depression
Measured: 3 months
PROMIS Emotional Distress: Depression - Short Form 8a
(8 items) Likert scale assessment of depression
Measured: 6 months
Smoking status
2 items that ask whether respondent has ever smoked >100 cigarettes and current smoking status.
Measured: Baseline
Smoking status
2 items that ask whether respondent has ever smoked >100 cigarettes and current smoking status.
Measured: 3 months
Smoking status
2 items that ask whether respondent has ever smoked >100 cigarettes and current smoking status.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start15 Oct 2020
- Primary completion15 Feb 2022
- Study completion15 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We anticipate enrolling 56 dyads of participants (2 per dyad). Each dyad will be randomized to either receive the intervention for 6 months or be placed on a 6-month waitlist and offered the opportunity to try the online intervention after final assessments are completed.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wendy Demark-Wahnefried, PhD, University of Alabama at Birmingham
- Investigators
- Wendy Demark-Wahnefried, PhD, RD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04132219
- Sponsor's protocol ID
- IRB-300003882
- Acronym
- DUET
- Status last verified
- May 2022
- First submitted
- 11 Oct 2019
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan at the moment to share IDP.
Publications
Pekmezi DW, Crane TE, Oster RA, Rogers LQ, Hoenemeyer T, Farrell D, Cole WW, Wolin K, Badr H, Demark-Wahnefried W. Rationale and Methods for a Randomized Controlled Trial of a Dyadic, Web-Based, Weight Loss Intervention among Cancer Survivors and Partners: The DUET Study. Nutrients. 2021 Sep 29;13(10):3472. doi: 10.3390/nu13103472.
PubMed 34684474Kaur H, Pekmezi D, E Crane T, Farrell D, Q Rogers L, Demark-Wahnefried W. Website Use and Associations With Behavior Change and Weight Loss in Cancer Survivors and Their Partners: Secondary Analysis of a Randomized Controlled Trial. J Med Internet Res. 2026 Jan 30;28:e86908. doi: 10.2196/86908.
PubMed 41617212Kaur H, Pavela G, Pekmezi DW, Rogers LQ, Cole WW, Parrish KB, Sayer RD, Wyatt HR, Crane TE, Badr H, Demark-Wahnefried W. Living together-does it help or hinder the pursuit of a healthful diet, physical activity, and weight loss among cancer survivors and their chosen partners? Support Care Cancer. 2024 Oct 3;32(10):700. doi: 10.1007/s00520-024-08907-3.
PubMed 39361227
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daughters, (dUdes), Mothers and othErs Fighting Cancer Together
- ClinicalTrials.gov ID
- NCT04132219
- Acronym / sponsor ID
- DUET / IRB-300003882
- Conditions
- Cancer, Overweight and Obesity
- Keywords
- cancer survivor, overweight, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 18 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- We anticipate enrolling 56 dyads of participants (2 per dyad). Each dyad will be randomized to either receive the intervention for 6 months or be placed on a 6-month waitlist and offered the opportunity to try the online intervention after final assessments are completed.
| Arm | Type | Receives |
|---|---|---|
| Immediate Intervention Group | Experimental | Behavioral: eHealth InterventionDyads 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. |
| Delayed Intervention Group | Other | Behavioral: eHealth InterventionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eHealth InterventionEvery week, each dyad member will receive a tailored text message that provides a new fun fact or that encourages them to log-on to the website to access findings of new research and how the results might apply to them. They will be directed to specific pages in the Web-based program and asked to select strategies from a list that they will practice during the upcoming week. Graphic displays of their progress will be provided along with SCT-based feedback. They will be directed to the website to record their behavioral goals for the upcoming week. Tips also will be provided for effective communication to enhance couple efficacy. All usage will be tracked to assess adherence. | Behavioural | Delayed Intervention Group, Immediate Intervention Group |
Primary outcome
Body Weight
Time frame: baseline
Change in measured body weight
Body Weight
Time frame: 6 months
Change in measured body weight
73 secondary outcomes
Waist Circumference
Time frame: baseline
Waist Circumference
Time frame: 6 months
Physical Activity (self-reported)
Time frame: Baseline
Physical Activity (self-reported)
Time frame: 3 months
Physical Activity (self-reported)
Time frame: 6 months
Physical Activity (objective)
Time frame: baseline
Physical Activity (objective)
Time frame: 6 months
Diet Quality
Time frame: baseline
Diet Quality
Time frame: 6 months
Physical Performance (endurance)
Time frame: Baseline
Physical Performance (endurance)
Time frame: 6 months
Physical Performance (lower body strength)
Time frame: Baseline
Physical Performance (lower body strength)
Time frame: 6 months
Physical Performance (agility)
Time frame: Baseline
Physical Performance (agility)
Time frame: 6 months
Physical Performance (gait speed)
Time frame: baseline
Physical Performance (gait speed)
Time frame: 6 months
Physical Performance (Balance)
Time frame: baseline
Physical Performance (Balance)
Time frame: 6 months
Self-efficacy for calorically restricted diet
Time frame: baseline
Self-efficacy for calorically restricted diet
Time frame: 3 months
Self-efficacy for calorically restricted diet
Time frame: 6 months
Self-efficacy for increased physical activity
Time frame: baseline
Self-efficacy for increased physical activity
Time frame: 3 months
Self-efficacy for increased physical activity
Time frame: 6 months
Social support for calorically restricted diet
Time frame: baseline
Social support for increased physical activity
Time frame: baseline
Social support for calorically restricted diet
Time frame: 3 months
Social support for increased physical activity
Time frame: 3 months
Social support for calorically restricted diet
Time frame: 6 months
Social support for increased physical activity
Time frame: 6 months
Barriers for increased physical activity
Time frame: baseline
Barriers for increased physical activity
Time frame: 3 months
Barriers for increased physical activity
Time frame: 6 months
Circulating insulin
Time frame: baseline
Circulating insulin
Time frame: 6 months
Circulating glucose
Time frame: baseline
Circulating glucose
Time frame: 6 months
Circulating IL-6
Time frame: baseline
Circulating IL-6
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- Background: PubMed 34684474Pekmezi DW, Crane TE, Oster RA, Rogers LQ, Hoenemeyer T, Farrell D, Cole WW, Wolin K, Badr H, Demark-Wahnefried W. Rationale and Methods for a Randomized Controlled Trial of a Dyadic, Web-Based, Weight Loss Intervention among Cancer Survivors and Partners: The DUET Study. Nutrients. 2021 Sep 29;13(10):3472. doi: 10.3390/nu13103472.
- Derived from this study: PubMed 41617212Kaur H, Pekmezi D, E Crane T, Farrell D, Q Rogers L, Demark-Wahnefried W. Website Use and Associations With Behavior Change and Weight Loss in Cancer Survivors and Their Partners: Secondary Analysis of a Randomized Controlled Trial. J Med Internet Res. 2026 Jan 30;28:e86908. doi: 10.2196/86908.
- Derived from this study: PubMed 39361227Kaur H, Pavela G, Pekmezi DW, Rogers LQ, Cole WW, Parrish KB, Sayer RD, Wyatt HR, Crane TE, Badr H, Demark-Wahnefried W. Living together-does it help or hinder the pursuit of a healthful diet, physical activity, and weight loss among cancer survivors and their chosen partners? Support Care Cancer. 2024 Oct 3;32(10):700. doi: 10.1007/s00520-024-08907-3.
- Individual participant dataSharing planned: No. There is no plan at the moment to share IDP.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendy Demark-Wahnefried, PhD, RD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eHealth Intervention in people with Cancer and Overweight and Obesity, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Weight (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04132219, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2022.