Weight Loss
Conditions
Brief summary
The objective of this study is to leverage existing social networks for health behavior change relevant to obesity and cardiovascular risk among immigrant populations in Southeast, Minnesota.
Interventions
BEHAVIORALCommunity-based mentoring and education sessions
Community-based mentoring and education sessions, group activities, and application of a community toolkit for healthy weight loss delivered by trained Health Promoters from Hispanic and Somali communities to their social networks.
Sponsors
Mayo Clinic
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Self-identification as Hispanic or Somali. * Member of a social network identified in the social network analysis. * Willingness to participate in all aspects of the study. * Provision of informed consent.
Exclusion criteria
* 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 in the intervention, but they will be excluded from the measurements and analyses.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Weight | Baseline, 6 months, 12 months | Difference in weight (measured in kilograms) from baseline to 6 months and from baseline to 12 months |
| Change in Waist Circumference From Baseline to 6 Months and From Baseline to 12 Months | Baseline, 6 months, 12 months | Measured to the nearest 0.1 cm at the narrowest part of the torso between the ribs and the iliac crest. |
| Change in "Life's Simple 6" Composite Score From Baseline to 6 Months and From Baseline to 12 Months | Baseline, 6 months, 12 months | Adapted from the American Heart Association standards based on health assessment data. Point values are assigned to each component: 2 points for ideal, 1 point for intermediate, 0 points for poor. The total sum allows for a continuous measure of cardiovascular health ranging from poor to ideal (0-12 points). |
| Lost >5% of Body Weight | 6 months, 12 months | Number of participants in each arm who lost a clinically significant amount of weight (\>5%). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Systolic Blood Pressure | Baseline, 6 months, 12 months | Measured three times and the average of the second and third readings will be used in analyses, reported in mmHg. Change from baseline to 6 months and from baseline to 12 months. |
| Change in Fasting Glucose Level | Baseline, 6 months, 12 months | 6 hours fasting glucose blood serum level, reported in mg/dL. Baseline to 6 months and baseline to 12 months. |
| Change in Low-density Lipoprotein (LDL) | Baseline, 6 months, 12 months | Change in LDL cholesterol blood serum level, reported in mg/dL. Baseline to 6 months and baseline to 12 months |
| Change in Dietary Quality | Baseline, 6 months, 12 months | 24-hour dietary recall collected using the Nutrition Data System for Research (NDSR) used to calculate the Healthy Eating index (HEI-2015). The HEI range is 0-100 with higher scores indicating healthier dietary quality. Scores can be further categorized as HEI≥69.3 optimal, HEI 56.9-69.2 intermediate, HEI\<56.9 poor. Change from baseline to 6 months and baseline to 12 months. |
| Change in Physical Activity | Baseline, 6 months, 12 months | Measured using the International Physical Activity Questionnaire (IPAQ) that assesses the number of minutes of mild, moderate, and vigorous physical activity over the previous 7 days, scores categorized as ≥150 min/wk moderate or ≥75 min/wk vigorous or ≥150 min/wk moderate+vigorous = optimal; 1-149 min/wk moderate or 1-74 min/wk vigorous or 1-149 min/wk moderate+vigorous = intermediate; no physical activity = poor. Baseline to 6 months and baseline to 12 months. For this study, we present IPAQ results as a continuous variable of MET minutes per week, which refers to the total amount of physical activity measured in Metabolic Equivalent of Task (MET) units over a week. Physical Activity Guidelines recommend achieving 500 to 1,000 MET minutes per week for significant health benefits. |
| Change in Diastolic Blood Pressure | Baseline, 6 months, 12 months | Chage from baseline to 6 months and from baseline to 12 months (mmHg) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMark Wieland, MD
Mayo Clinic
Participant flow
Recruitment details
The social networks (units of randomization) were defined as the Health Promoter (HP) and their friend/family social network members. At 0-5 months, this included 29 Hispanic and 22 Somali social networks. At 6-11 months, this included 23 Hispanic and 22 Somali social networks. At 12-24 months, this included 23 Hispanic and 22 Somali social networks.
Pre-assignment details
The units of randomization were social networks defined by a Health Promoter and their network members. Randomization occurred after all participants were enrolled and baseline measures completed. Constrained randomization was used with the assignment selected from a set of allocations balanced on ethnicity, age, network size, and sex of the HPs. The period titles are referring to the time after starting intervention.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 45.1 years STANDARD_DEVIATION 14.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 129 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 99 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Life's Simple 6 Composite | 6.4 units on a scale STANDARD_DEVIATION 1.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 97 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) White | 146 Participants |
| Region of Enrollment United States | 229 participants |
| Sex/Gender, Customized Female | 273 Participants |
| Sex/Gender, Customized Male | 87 Participants |
| Sex/Gender, Customized Missing | 2 Participants |
| Sex/Gender, Customized Other | 17 Participants |
| Waist Circumference | 101.8 Centimeters STANDARD_DEVIATION 12.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 246 | 0 / 229 |
| other Total, other adverse events | 0 / 246 | 0 / 229 |
| serious Total, serious adverse events | 0 / 246 | 0 / 229 |
Outcome results
None listed