Weight LossNCT03605888
Koa Family: California's Obesity Prevention Project
A study testing Koa Family in people with Weight Loss and Diet Habit, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of this study is to learn if a new whole-person lifestyle program improves the health of low-income mothers. Read more about this study
- Who is it for?
- Ages 18 to 47 years, women only
- Conditions the study is for
- Weight Loss, Diet Habit, Physical Activity
- What is being tested?
- Koa Family
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2018to 26 Jun 2020
- 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 to 47 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Comfortable speaking and reading English
- Primary caregiver for ≥1 child, aged 3-17, who lives at home
- Living in a low-income household (at or below 185% of the Federal Poverty Level)
- Living in the study site catchment area
- Ability to receive and send text messages
- BMI ≥ 25 kg/m2 for RCT study
- BMI ≥18.5 and <25 kg/m2 for exploratory study
Who cannot join
- Pregnant
- 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 from study site catchment area during the one-year study period
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Institute for Population Health Improvement
Sacramento, California, 95816
About this study
Official title: Koa Family: A Study of Improving Diet, Physical Activity, Weight, and Well-being Among Low-income Mothers in California
The purpose of this study is to learn if a new whole-person lifestyle program improves the health of low-income mothers.
Read the detailed description
This study will employ a randomized controlled trial (RCT) design to test a newly developed obesity reduction program, Koa Family, among overweight or obese mothers. An exploratory, uncontrolled study will assess its acceptance among normal-weight mothers.
Koa Family consists of a 6-month whole-person lifestyle program (WPLP) combined with text messaging and social media support and the opportunity to take part in a neighborhood tree planting campaign. This multi-pronged program is intended to reduce weight in the short-term while building self-empowerment and connections to community resources so that participants can sustain long-term weight loss.
Koa Family will be implemented in select communities in Yolo and Sacramento counties, California. Overweight or obese study participants will be randomized to either an intervention or control group; all normal-weight participants will be assigned to the intervention. All participants will complete a survey and have their height and weight measured at baseline and 3-, 6-, 9- and 12-month follow-up. Intervention participants will also take part in a focus group at the 3-month midpoint of the intervention.
- Conditions
- Weight Loss, Diet Habit, Physical Activity, Overweight and Obesity
- Being tested
- Koa Family
- Keywords
- Nutrition
- Medical subject headings
- Weight Loss, Feeding Behavior, Motor Activity, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Koa FamilyBehavioural
Koa Family is a 6-month program consisting of a whole-person lifestyle program (WPLP) combined with text messaging and social media support and a neighborhood tree planting campaign. The WPLP will bring groups of 8 to 10 mothers living in the same community together for 22 weekly 90-minute support sessions. Each session will cover a topic on whole-person living, including healthy eating, physical activity, stress reduction, coping, and well-being. Participants will receive brief text messages on their cell phones to encourage healthy lifestyle choices. Participants also will be invited to join a "secret" Facebook group where they can support one another in healthy lifestyle change. Finally, participants will have an opportunity to take part in a neighborhood tree planting campaign.
| Study group | Role | What they receive |
|---|---|---|
| RCT Intervention | Experimental | Overweight or obese (BMI ≥ 25 kg/m2) participants randomized to the Koa Family. intervention Receives: Behavioral: Koa Family |
| RCT Control | No intervention | Overweight or obese (BMI ≥ 25 kg/m2) participants randomized to the control group. |
| Exploratory | Other | Normal-weight mothers (BMI 18.5-24.9 kg/m2) assigned to the Koa Family intervention. Receives: Behavioral: Koa Family |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Mass Index (kg/m2)
Objectively measured
Measured: 12 months
Secondary outcomes (4)
Change in diet quality
Fruit and vegetable consumption and other indicators calculated from 24-hour dietary recall
Measured: 12 months
Change in physical activity
Self-report moderate-intensity equivalent minutes per week calculated from the BRFSS Physical Activity Rotating Core questionnaire
Measured: 12 months
Change in health-related quality of life
Summary score from SF-36v2 instrument
Measured: 12 months
Cost effectiveness
Dollars per change in BMI and quality-adjusted life-year (QALY)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start16 Aug 2018
- Primary completion26 Jun 2020
- Study completion26 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies 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
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- California Department of Health Services, United States Department of Agriculture (USDA), California Department of Social Services, CAL FIRE
- Responsible party
- Sponsor
- Investigators
- Desiree R Backman, DrPH, MS, RD, Principal investigator, UC DavisKenneth W Kizer, MD, MPH, Study director, UC Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03605888
- Sponsor's protocol ID
- 1229056
- Other IDs
- 2017-088
- Status last verified
- Jul 2020
- First submitted
- 17 Jul 2018
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Koa Family: A Study of Improving Diet, Physical Activity, Weight, and Well-being Among Low-income Mothers in California
- ClinicalTrials.gov ID
- NCT03605888
- Acronym / sponsor ID
- 1229056
- Conditions
- Weight Loss, Diet Habit, Physical Activity, Overweight and Obesity
- Keywords
- Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- California Department of Health Services, United States Department of Agriculture (USDA), California Department of Social Services, CAL FIRE
- Study start
- 16 Aug 2018 (actual)
- Primary completion
- 26 Jun 2020 (actual)
- Study completion
- 26 Jun 2020 (actual)
- First posted
- 30 Jul 2018 (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 study is to learn if a new whole-person lifestyle program improves the health of low-income mothers.
Detailed description
This study will employ a randomized controlled trial (RCT) design to test a newly developed obesity reduction program, Koa Family, among overweight or obese mothers. An exploratory, uncontrolled study will assess its acceptance among normal-weight mothers.
Koa Family consists of a 6-month whole-person lifestyle program (WPLP) combined with text messaging and social media support and the opportunity to take part in a neighborhood tree planting campaign. This multi-pronged program is intended to reduce weight in the short-term while building self-empowerment and connections to community resources so that participants can sustain long-term weight loss.
Koa Family will be implemented in select communities in Yolo and Sacramento counties, California. Overweight or obese study participants will be randomized to either an intervention or control group; all normal-weight participants will be assigned to the intervention. All participants will complete a survey and have their height and weight measured at baseline and 3-, 6-, 9- and 12-month follow-up. Intervention participants will also take part in a focus group at the 3-month midpoint of the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RCT Intervention | Experimental | Behavioral: Koa FamilyOverweight or obese (BMI ≥ 25 kg/m2) participants randomized to the Koa Family. intervention |
| RCT Control | No intervention | –Overweight or obese (BMI ≥ 25 kg/m2) participants randomized to the control group. |
| Exploratory | Other | Behavioral: Koa FamilyNormal-weight mothers (BMI 18.5-24.9 kg/m2) assigned to the Koa Family intervention. |
Who may qualify
- Ages
- 18 to 47 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Comfortable speaking and reading English
- Primary caregiver for ≥1 child, aged 3-17, who lives at home
- Living in a low-income household (at or below 185% of the Federal Poverty Level)
- Living in the study site catchment area
- Ability to receive and send text messages
Key exclusion criteria (13 listed)
- Pregnant
- 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 |
|---|---|---|
| Koa FamilyKoa Family is a 6-month program consisting of a whole-person lifestyle program (WPLP) combined with text messaging and social media support and a neighborhood tree planting campaign. The WPLP will bring groups of 8 to 10 mothers living in the same community together for 22 weekly 90-minute support sessions. Each session will cover a topic on whole-person living, including healthy eating, physical activity, stress reduction, coping, and well-being. Participants will receive brief text messages on their cell phones to encourage healthy lifestyle choices. Participants also will be invited to join a "secret" Facebook group where they can support one another in healthy lifestyle change. Finally, participants will have an opportunity to take part in a neighborhood tree planting campaign. | Behavioural | Exploratory, RCT Intervention |
Primary outcome
Change in Body Mass Index (kg/m2)
Time frame: 12 months
Objectively measured
4 secondary outcomes
Change in diet quality
Time frame: 12 months
Change in physical activity
Time frame: 12 months
Change in health-related quality of life
Time frame: 12 months
Cost effectiveness
Time frame: 12 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 23 Jul 2020.
- 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 R Backman, DrPH, MS, RD principal investigator
UC Davis
Kenneth W Kizer, MD, MPH study director
UC Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Koa Family in people with Weight Loss and Diet Habit, 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 7 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 23 Jul 2020. 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 in Body Mass Index (kg/m2) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2020.