Diet, HealthyHICNCT04273503
Pilot Social Network Weight Loss Intervention
A study testing Mentoring/educational session in people with Diet, Healthy and Weight Loss, run by Mayo Clinic at 1 site in United States.
Trial summary
Specific Aim #1: Pilot test a social network-informed CBPR-derived health promotion program for feasibility outcomes with overweight or obese adults from two immigrant communities. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy, Weight Loss
- What is being tested?
- Mentoring/educational session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2020to 30 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- self-identification as Hispanic or Somali
- member of an HPs social network
- age≥18 and <65
- willingness to participate in all aspects of the study
- provision of informed consent.
Who cannot join
- pregnancy at the time of enrollment
- serious medical conditions or disabilities that would make physical activity difficult.
- To avoid stigmatization, a normal weight (BMI<25) will not exclude individuals from participating, but they will be excluded from the measurements and analyses.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Healthy Immigrant Community: Pilot Social Network Weight Loss Intervention
Specific Aim #1: Pilot test a social network-informed CBPR-derived health promotion program for feasibility outcomes with overweight or obese adults from two immigrant communities.
Specific Aim #2: Assess the preliminary impact of embedding a social network-informed CBPR-derived intervention within a regional health promotion resource hub on sustainability and uptake outcomes.
Read the detailed description
The intervention will consist of 12 community-based mentoring and education sessions, group activities and application of a community toolkit for healthy weight loss delivered by trained interventionists from Hispanic and Somali communities to their social networks. Using a pre-post study design, 4 social networks of adults with approximately 32 network participants will receive the intervention. Primary outcomes, measured 3 months after implementation, will include feasibility measures of acceptability, implementation, and practicality. Secondary outcomes will include BMI, waist circumference, blood pressure, fasting blood glucose, total cholesterol, physical activity level, dietary change, and health-related quality of life.
Eligibility criteria include (1) self-identification as Hispanic or Somali, (2) member of an HPs social network, (3) age≥18 and <65 (4) willingness to participate in all aspects of the study; and (5) provision of informed consent. Exclusion criteria include (1) pregnancy at the time of enrollment and (2) serious medical conditions or disabilities that would make physical activity difficult.
We will test how best to integrate a social network intervention within an existing evidence-based regional health promotion infrastructure (WellConnect) that will enhance its potential dissemination and community-wide uptake
- Conditions
- Diet, Healthy, Weight Loss
- Being tested
- Mentoring/educational session
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mentoring/educational sessionBehavioural
12 mentoring/educational sessions focused on physical activity and healthy nutrition by Mayo Clinic experts.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | All participants will receive education on maintaining a healthy diet and improving physical activity. Receives: Behavioral: Mentoring/educational session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
To what extent did was the intervention judged as relevant, satisfying, or helpful to HPs and participants? Interviews with HPs; focus groups and survey with participants.
Measured: 12 weeks
Secondary outcomes (5)
Weight
Weight will be measured to the nearest 0.1 kg using a portable scale (Seca 880 Digital Floor Scale). BMI is calculated as weight (kg)/height squared (m2).
Measured: 12 weeks
Waist circumference
Waist circumference will be measured to the nearest 0.1 cm at the narrowest part of the torso between the ribs and the iliac crest. Participants will remove all excess clothing prior to the measurement and smooth the remaining clothing against the skin. Two measurements will be taken; if the difference between the two measures is more than 2.0 cm, a third measurement will be taken. The average of the two closest measures will be used for analyses.
Measured: 12 weeks
Glucose
Collected by a single finger prick. Participants will be asked to refrain from eating for at least 6 hours prior to testing. Samples used for testing are whole blood from a fingerstick collected in a lithium heparin coated capillary tube.
Measured: 12 weeks
Cholesterol
Collected by a single finger prick. Participants will be asked to refrain from eating for at least 6 hours prior to testing. The portable Whole Blood Lipid Screen Cholestech LDX Analyzer will be used to analyze specimens, which combines enzymatic methodology and solid-phase technology measured by reflectance photometry to measure total cholesterol, HDL cholesterol, triglycerides and glucose in whole blood. LDL cholesterol is a calculated value. Samples used for testing are whole blood from a fingerstick collected in a lithium heparin coated capillary tube. Results will be recorded at the site of collection and samples will be destroyed upon recording of results.
Measured: 12 weeks
Height
Height will be measured to the nearest 0.1 cm at baseline only using a stadiometer.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start28 Jan 2020
- Primary completion26 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, HealthyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Behavioral intervention
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark L Wieland, Mayo Clinic
- Investigators
- Mark Wieland, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04273503
- Sponsor's protocol ID
- 19-011574
- Acronym
- HIC
- Status last verified
- Jul 2021
- First submitted
- 12 Feb 2020
- Last updated
- 30 Jul 2021
- 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 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Immigrant Community: Pilot Social Network Weight Loss Intervention
- ClinicalTrials.gov ID
- NCT04273503
- Acronym / sponsor ID
- HIC / 19-011574
- Conditions
- Diet, Healthy, Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 28 Jan 2020 (actual)
- Primary completion
- 26 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 18 Feb 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.
Specific Aim #1: Pilot test a social network-informed CBPR-derived health promotion program for feasibility outcomes with overweight or obese adults from two immigrant communities.
Specific Aim #2: Assess the preliminary impact of embedding a social network-informed CBPR-derived intervention within a regional health promotion resource hub on sustainability and uptake outcomes.
Detailed description
The intervention will consist of 12 community-based mentoring and education sessions, group activities and application of a community toolkit for healthy weight loss delivered by trained interventionists from Hispanic and Somali communities to their social networks. Using a pre-post study design, 4 social networks of adults with approximately 32 network participants will receive the intervention. Primary outcomes, measured 3 months after implementation, will include feasibility measures of acceptability, implementation, and practicality. Secondary outcomes will include BMI, waist circumference, blood pressure, fasting blood glucose, total cholesterol, physical activity level, dietary change, and health-related quality of life.
Eligibility criteria include (1) self-identification as Hispanic or Somali, (2) member of an HPs social network, (3) age≥18 and <65 (4) willingness to participate in all aspects of the study; and (5) provision of informed consent. Exclusion criteria include (1) pregnancy at the time of enrollment and (2) serious medical conditions or disabilities that would make physical activity difficult.
We will test how best to integrate a social network intervention within an existing evidence-based regional health promotion infrastructure (WellConnect) that will enhance its potential dissemination and community-wide uptake
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Behavioral intervention
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Mentoring/educational sessionAll participants will receive education on maintaining a healthy diet and improving physical activity. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- self-identification as Hispanic or Somali
- member of an HPs social network
- age≥18 and <65
- willingness to participate in all aspects of the study
- provision of informed consent.
Key exclusion criteria (3 listed)
- pregnancy at the time of enrollment
- serious medical conditions or disabilities that would make physical activity difficult.
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 |
|---|---|---|
| Mentoring/educational session12 mentoring/educational sessions focused on physical activity and healthy nutrition by Mayo Clinic experts. | Behavioural | Intervention |
Primary outcome
Acceptability
Time frame: 12 weeks
To what extent did was the intervention judged as relevant, satisfying, or helpful to HPs and participants? Interviews with HPs; focus groups and survey with participants.
5 secondary outcomes
Weight
Time frame: 12 weeks
Waist circumference
Time frame: 12 weeks
Glucose
Time frame: 12 weeks
Cholesterol
Time frame: 12 weeks
Height
Time frame: 12 weeks
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 30 Jul 2021.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Mark Wieland, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mentoring/educational session in people with Diet, Healthy and Weight Loss, run by Mayo Clinic 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 5 inclusion and 3 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 30 Jul 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?
Acceptability (time frame: 12 weeks). 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 30 Jul 2021.