ObesityKFSNCT04662593
Koa Family Study--A Community-Based Intervention to Improve Health and Well-Being
A study testing Whole Health Program in people with Obesity and Overweight, run by University of California, Davis at 1 site in United States.
Trial summary
Wholehearted living touches every aspect of life, from eating nourishing foods, to enjoying enough physical activity, to cultivating relationships that support healthy choices, to joining with neighbors to stand up for positive changes, and more. Read more about this study
- Who is it for?
- Ages 21 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight, Diet, Healthy
- What is being tested?
- Whole Health Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2021to 23 Sep 2021
- 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 21 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female
- 21-45 years old
- comfortable speaking and reading English (all race/ethnicities are welcomed to participate)
- living in a low-income household (at or below 185% of the Federal Poverty Level)
- living in the Sacramento area
- familiarity with Facebook, Zoom, and texting
- access to a smartphone or high-speed internet (via a tablet or computer)
- overweight or obese (BMI≥25 and <39.9)
Who cannot join
- pregnancy;
- breastfeeding;
- within 2 years postpartum;
- life-threatening illness;
- institutionalization (i.e., not free-living in the community);
- moderate to severe mental illness;
Show all 13Show fewer
- receiving nutrition therapy from a health or health care provider (licensed or unlicensed);
- had or are considering bariatric surgery;
- medically diagnosed eating disorder;
- taking medication that affects weight;
- thyroid disease;
- Type 1 or Type 2 diabetes without medical clearance from the participant's physician;
- plans to move away during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Wholehearted living touches every aspect of life, from eating nourishing foods, to enjoying enough physical activity, to cultivating relationships that support healthy choices, to joining with neighbors to stand up for positive changes, and more. Unfortunately, for many low-income Californians, the idea of wholehearted living is an aspiration and not a reality. Koa Family: Strong, Healthy, Whole is an approach designed to make wholehearted living available for all.
The Approach Koa Family is a 4-month journey to establish "micro-communities" of women supporting one another- mind, body, and spirit. The foundation of this approach is a new, custom-designed, online Whole Health Program (WHP) that addresses healthy eating, physical activity, and weight management within the context of wholehearted living. Low-income women and a lifestyle coach will meet weekly in a virtual platform to learn, experience, grow, and thrive as they reach their diet, physical activity, and weight management goals.
Read more
Participants in the WHP will receive additional encouragement and access to local resources through a private and secure Facebook group. The group will provide a place for women to continue their wholehearted health journeys beyond the weekly meetings. Koa Family participants also will be invited to take part in a neighborhood tree planting campaign to create real, long-lasting, healthy changes to the environment in which they live.
The Study Koa Family, with WHP at its core, is the product of extensive formative research both nationally and within low-income California communities. Koa Family will be introduced in Sacramento County in February 2021. It will be evaluated for effectiveness among 120 low-income, Supplemental Nutrition Assistance Program (SNAP)-Ed eligible women using a randomized controlled trial study design, the gold standard for assessing effectiveness of an intervention. Outcomes include changes in Body Mass Index, diet, and physical activity measured at 4 and 6 months from baseline. An economic analysis will assess the cost-effectiveness of Koa Family, while qualitative methods will identify mediating factors related to the study outcomes.
Funding Koa Family is a project of the Population Health Group at the University of California, Davis, Center for Healthcare Policy and Research. Funding is provided by the United States Department of Agriculture Supplemental Nutrition Assistance Program-Education and the California Department of Forestry and Fire Protection (CalFIRE).
Read the detailed description
The Koa Family Study is a randomized controlled trial testing a 17-week intervention, the Koa Family Program (KFP), consisting of three components: (1) the Whole Health Program (WHP)-a weekly, online group session facilitated by a health coach using the Zoom platform; (2) social media support including texting of health messages and a private Facebook group; and (3) a community empowerment arm designed around tree planting. The KFP addresses well-being from physical, mental, and social health perspectives. The program is intended to increase weight loss while fostering self-empowerment and connections to community resources to help sustain long-term weight management.
This study will test the following hypotheses:
- Intervention participants, consisting of low-income overweight or obese women living in urban communities, receiving the KFP will have greater average weight loss and reduction in body mass index (BMI) than participants in the control group (who do not participate in the KFP);
- KFP participants will show greater improvements in dietary practices compared with participants in the control group;
- KFP participants will have greater increases in physical activity compared with control group participants;
- KFP participants will have greater improvements in measures of well-being) compared with control group participants;
- There will be a dose-response effect where greater engagement with the components of the KFP will be associated with larger improvements in the above endpoints (weight, diet, physical activity, and well-being).
Study design. The primary study will employ a prospective, randomized controlled trial (RCT) design. One hundred twenty eligible participants will be assigned to either the intervention (n=60) or control (n=60) group.
Intervention. The intervention group (n=60) will participate in the 17-week, KFP that supports physical, mental, and social well-being. It consists of: (1) theWHP-a weekly, online group session facilitated by a health coach using the Zoom platform; (2) social media support including texting of health messages and a private Facebook group; and (3) a community empowerment arm designed around tree planting.
The WHP is a small group-focused intervention designed to build "micro-communities" of mothers supporting one another in healthy living. Groups of 5-10 women living in the same community will meet online for 75 minutes weekly via the Zoom platform, for a total of 17 sessions. Each weekly session will cover a topic on whole-person living, including healthy eating, physical activity, weight management, coping, and resilience. The content of the WHP is based, in part, on the Centers for Disease Control and Prevention's National Diabetes Prevention Program (PT2) and Family Hui, a peer-led, women's group program to increase positive parenting skills and help families thrive.
For social media support, the intervention participants will receive brief text messages on their cell phones to encourage healthy lifestyle choices and connect to supportive community events and resources. EZTexting will be used to send text messages to participants. The participants also will be invited to join a private Facebook community, linked to each WHP group.
The principles and practice for tree planting and stewardship will be taught within the WHP sessions. If public health policy at the time, relating to managing Coronavirus Disease (COVID)-19 permits, participants may choose to participate in community tree plantings while complying with public health directives.
The control group participants will be enrolled for study measurements only and after the intervention period, will receive information based on what is proven effective in the RCT. This information will be delivered in a series of three webinars delivered after the last study data are collected at 25 weeks after baseline.
Data Collection. All participants will be asked to complete a phone-based, questionnaire administered by trained research staff. It will take about 50 minutes to complete the questionnaire. Questions will cover diet, physical activity, and well-being. The questionnaire will be administered at baseline, at week 18 after completion of the 17-week intervention, and at week 26 of the study.
At about week 8, an online focus group will be conducted as part of one of the sessions to qualitatively assess participants' experiences with the KFP.
Weight will be collected, daily, through a research-quality, Bluetooth-enabled scale that can transmit participant weights via the Internet to a secure server.
- Conditions
- Obesity, Overweight, Diet, Healthy, Social Interaction, Weight Loss
- Being tested
- Whole Health Program
- Medical subject headings
- Obesity, Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Health ProgramBehavioural
A mind-body-spirit intervention to improve health and well-being including weight loss.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The intervention group participates in a 17-week whole health program including:
1. Weekly, small group online meetings with a health coach;
2. Supportive social media including a private Facebook group and selective text messaging;
3. Exposure to community tree planting and stewardship (through live streaming or in-person if COVID-19 public health guidance at the time, permits. Receives: Behavioral: Whole Health Program |
| Control Group | No intervention | The control group participates only in questionnaire data collection at baseline, 4 months, and 6 months as well as daily weighing. Control group participants will be offered 3 web-based seminars (webinars) highlighting the effective lifestyle approaches demonstrated in the study and intervention group health education materials. The webinars and materials will be provided after the 6-month data collection which concludes the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Weight at 4 Months
Weight (kg) measured with an electronic scale
Measured: Difference in weight between baseline and 4 months
Change from Baseline Weight at 6 Months
Weight (kg) measured with an electronic scale
Measured: Difference in weight between baseline and 6 months
Change from Baseline Body Mass Index (BMI) at 4 Months
weight (kg)/height (m) x height (m)
Measured: Difference in BMI between baseline and 4 months
Change from Baseline Body Mass Index (BMI) at 6 Months
weight (kg)/height (m) x height (m)
Measured: Difference in BMI between baseline and 6 months
Change from Baseline Diet at 4 Months
Measured with the Dietary Screener Questionnaire (NHANES 2009-10) to examine quality of participants' diet
Measured: Difference in diet between baseline and 4 months
Change from Baseline Diet at 6 Months
Measured with the Dietary Screener Questionnaire (NHANES 2009-10) to examine quality of participants' diet
Measured: Difference in diet between baseline and 6 months
Change from Baseline Physical Activity (PA) at 4 Months
Measured using the Centers for Disease Control and Prevention Behavioral Risk Factor Surveillance Survey Physical Activity Module
Measured: Difference in PA between baseline and 4 months
Change from Baseline Physical Activity (PA) at 6 Months
Measured using the Centers for Disease Control and Prevention Behavioral Risk Factor Surveillance Survey Physical Activity Module
Measured: Difference in PA between baseline and 6 months
Change from Baseline Health-Related Well-being at 4 Months
Well-being and general health measured with Short Form-36v2; There are 8 sections each scored 0-100 with a high score indicating less disability
Measured: Difference in health-related well-being between baseline and 4 months
Change from Baseline Health-Related Well-being at 6 Months
Well-being and general health measured with Short Form-36v2
Measured: Difference in health-related well-being between baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start4 Jan 2021
- Primary completion13 Sep 2021
- Study completion23 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Desiree Backman, DrPH, MS, RD, Principal investigator, UC Davis Center for Healthcare Policy and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04662593
- Sponsor's protocol ID
- 1668154
- Acronym
- KFS
- Status last verified
- Oct 2021
- First submitted
- 1 Dec 2020
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Flegal KM, Carroll MD, Kit BK, Ogden CL. Prevalence of obesity and trends in the distribution of body mass index among US adults, 1999-2010. JAMA. 2012 Feb 1;307(5):491-7. doi: 10.1001/jama.2012.39. Epub 2012 Jan 17.
PubMed 22253363Abdelaal M, le Roux CW, Docherty NG. Morbidity and mortality associated with obesity. Ann Transl Med. 2017 Apr;5(7):161. doi: 10.21037/atm.2017.03.107.
PubMed 28480197
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Koa Family Study--A Community-Based Intervention to Improve Health and Well-Being
- ClinicalTrials.gov ID
- NCT04662593
- Acronym / sponsor ID
- KFS / 1668154
- Conditions
- Obesity, Overweight, Diet, Healthy, Social Interaction, Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 13 Sep 2021 (actual)
- Study completion
- 23 Sep 2021 (actual)
- First posted
- 10 Dec 2020 (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.
Wholehearted living touches every aspect of life, from eating nourishing foods, to enjoying enough physical activity, to cultivating relationships that support healthy choices, to joining with neighbors to stand up for positive changes, and more. Unfortunately, for many low-income Californians, the idea of wholehearted living is an aspiration and not a reality. Koa Family: Strong, Healthy, Whole is an approach designed to make wholehearted living available for all.
The Approach Koa Family is a 4-month journey to establish "micro-communities" of women supporting one another- mind, body, and spirit. The foundation of this approach is a new, custom-designed, online Whole Health Program (WHP) that addresses healthy eating, physical activity, and weight management within the context of wholehearted living. Low-income women and a lifestyle coach will meet weekly in a virtual platform to learn, experience, grow, and thrive as they reach their diet, physical activity, and weight management goals.
Participants in the WHP will receive additional encouragement and access to local resources through a private and secure Facebook group. The group will provide a place for women to continue their wholehearted health journeys beyond the weekly meetings. Koa Family participants also will be invited to take part in a neighborhood tree planting campaign to create real, long-lasting, healthy changes to the environment in which they live.
The Study Koa Family, with WHP at its core, is the product of extensive formative research both nationally and within low-income California communities. Koa Family will be introduced in Sacramento County in February 2021. It will be evaluated for effectiveness among 120 low-income, Supplemental Nutrition Assistance Program (SNAP)-Ed eligible women using a randomized controlled trial study design, the gold standard for assessing effectiveness of an intervention. Outcomes include changes in Body Mass Index, diet, and physical activity measured at 4 and 6 months from baseline. An economic analysis will assess the cost-effectiveness of Koa Family, while qualitative methods will identify mediating factors related to the study outcomes.
Funding Koa Family is a project of the Population Health Group at the University of California, Davis, Center for Healthcare Policy and Research. Funding is provided by the United States Department of Agriculture Supplemental Nutrition Assistance Program-Education and the California Department of Forestry and Fire Protection (CalFIRE).
Detailed description
The Koa Family Study is a randomized controlled trial testing a 17-week intervention, the Koa Family Program (KFP), consisting of three components: (1) the Whole Health Program (WHP)-a weekly, online group session facilitated by a health coach using the Zoom platform; (2) social media support including texting of health messages and a private Facebook group; and (3) a community empowerment arm designed around tree planting. The KFP addresses well-being from physical, mental, and social health perspectives. The program is intended to increase weight loss while fostering self-empowerment and connections to community resources to help sustain long-term weight management.
This study will test the following hypotheses:
- Intervention participants, consisting of low-income overweight or obese women living in urban communities, receiving the KFP will have greater average weight loss and reduction in body mass index (BMI) than participants in the control group (who do not participate in the KFP);
- KFP participants will show greater improvements in dietary practices compared with participants in the control group;
- KFP participants will have greater increases in physical activity compared with control group participants;
- KFP participants will have greater improvements in measures of well-being) compared with control group participants;
- There will be a dose-response effect where greater engagement with the components of the KFP will be associated with larger improvements in the above endpoints (weight, diet, physical activity, and well-being).
Study design. The primary study will employ a prospective, randomized controlled trial (RCT) design. One hundred twenty eligible participants will be assigned to either the intervention (n=60) or control (n=60) group.
Intervention. The intervention group (n=60) will participate in the 17-week, KFP that supports physical, mental, and social well-being. It consists of: (1) theWHP-a weekly, online group session facilitated by a health coach using the Zoom platform; (2) social media support including texting of health messages and a private Facebook group; and (3) a community empowerment arm designed around tree planting.
The WHP is a small group-focused intervention designed to build "micro-communities" of mothers supporting one another in healthy living. Groups of 5-10 women living in the same community will meet online for 75 minutes weekly via the Zoom platform, for a total of 17 sessions. Each weekly session will cover a topic on whole-person living, including healthy eating, physical activity, weight management, coping, and resilience. The content of the WHP is based, in part, on the Centers for Disease Control and Prevention's National Diabetes Prevention Program (PT2) and Family Hui, a peer-led, women's group program to increase positive parenting skills and help families thrive.
For social media support, the intervention participants will receive brief text messages on their cell phones to encourage healthy lifestyle choices and connect to supportive community events and resources. EZTexting will be used to send text messages to participants. The participants also will be invited to join a private Facebook community, linked to each WHP group.
The principles and practice for tree planting and stewardship will be taught within the WHP sessions. If public health policy at the time, relating to managing Coronavirus Disease (COVID)-19 permits, participants may choose to participate in community tree plantings while complying with public health directives.
The control group participants will be enrolled for study measurements only and after the intervention period, will receive information based on what is proven effective in the RCT. This information will be delivered in a series of three webinars delivered after the last study data are collected at 25 weeks after baseline.
Data Collection. All participants will be asked to complete a phone-based, questionnaire administered by trained research staff. It will take about 50 minutes to complete the questionnaire. Questions will cover diet, physical activity, and well-being. The questionnaire will be administered at baseline, at week 18 after completion of the 17-week intervention, and at week 26 of the study.
At about week 8, an online focus group will be conducted as part of one of the sessions to qualitatively assess participants' experiences with the KFP.
Weight will be collected, daily, through a research-quality, Bluetooth-enabled scale that can transmit participant weights via the Internet to a secure server.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Whole Health ProgramThe intervention group participates in a 17-week whole health program including: 1. Weekly, small group online meetings with a health coach; 2. Supportive social media including a private Facebook group and selective text messaging; 3. Exposure to community tree planting and stewardship (through live streaming or in-person if COVID-19 public health guidance at the time, permits. |
| Control Group | No intervention | –The control group participates only in questionnaire data collection at baseline, 4 months, and 6 months as well as daily weighing. Control group participants will be offered 3 web-based seminars (webinars) highlighting the effective lifestyle approaches demonstrated in the study and intervention group health education materials. The webinars and materials will be provided after the 6-month data collection which concludes the study. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- female
- 21-45 years old
- comfortable speaking and reading English (all race/ethnicities are welcomed to participate)
- living in a low-income household (at or below 185% of the Federal Poverty Level)
- living in the Sacramento area
Key exclusion criteria (13 listed)
- pregnancy;
- breastfeeding;
- within 2 years postpartum;
- life-threatening illness;
- institutionalization (i.e., not free-living in the community);
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 |
|---|---|---|
| Whole Health ProgramA mind-body-spirit intervention to improve health and well-being including weight loss. | Behavioural | Intervention Group |
Primary outcome
Change from Baseline Weight at 4 Months
Time frame: Difference in weight between baseline and 4 months
Weight (kg) measured with an electronic scale
Change from Baseline Weight at 6 Months
Time frame: Difference in weight between baseline and 6 months
Weight (kg) measured with an electronic scale
Change from Baseline Body Mass Index (BMI) at 4 Months
Time frame: Difference in BMI between baseline and 4 months
weight (kg)/height (m) x height (m)
Change from Baseline Body Mass Index (BMI) at 6 Months
Time frame: Difference in BMI between baseline and 6 months
weight (kg)/height (m) x height (m)
Change from Baseline Diet at 4 Months
Time frame: Difference in diet between baseline and 4 months
Measured with the Dietary Screener Questionnaire (NHANES 2009-10) to examine quality of participants' diet
Change from Baseline Diet at 6 Months
Time frame: Difference in diet between baseline and 6 months
Measured with the Dietary Screener Questionnaire (NHANES 2009-10) to examine quality of participants' diet
Change from Baseline Physical Activity (PA) at 4 Months
Time frame: Difference in PA between baseline and 4 months
Measured using the Centers for Disease Control and Prevention Behavioral Risk Factor Surveillance Survey Physical Activity Module
Change from Baseline Physical Activity (PA) at 6 Months
Time frame: Difference in PA between baseline and 6 months
Measured using the Centers for Disease Control and Prevention Behavioral Risk Factor Surveillance Survey Physical Activity Module
Change from Baseline Health-Related Well-being at 4 Months
Time frame: Difference in health-related well-being between baseline and 4 months
Well-being and general health measured with Short Form-36v2; There are 8 sections each scored 0-100 with a high score indicating less disability
Change from Baseline Health-Related Well-being at 6 Months
Time frame: Difference in health-related well-being between baseline and 6 months
Well-being and general health measured with Short Form-36v2
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 11 Oct 2021.
- Background: PubMed 22253363Flegal KM, Carroll MD, Kit BK, Ogden CL. Prevalence of obesity and trends in the distribution of body mass index among US adults, 1999-2010. JAMA. 2012 Feb 1;307(5):491-7. doi: 10.1001/jama.2012.39. Epub 2012 Jan 17.
- Background: PubMed 28480197Abdelaal M, le Roux CW, Docherty NG. Morbidity and mortality associated with obesity. Ann Transl Med. 2017 Apr;5(7):161. doi: 10.21037/atm.2017.03.107.
- Individual participant dataSharing planned: No
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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.
Desiree Backman, DrPH, MS, RD principal investigator
UC Davis Center for Healthcare Policy and Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole Health Program in people with Obesity and Overweight, run by University of California, Davis 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 8 inclusion and 13 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 11 Oct 2021. 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?
Change from Baseline Weight at 4 Months (time frame: Difference in weight between baseline and 4 months). The study lists 10 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 NCT04662593, which also lists 2 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 11 Oct 2021.