Preconceptional Health Promotion in Low- Income Rural Communities: Randomized

Trial Results From The Central Pennsylvania Women’s Health Study

(CePAWHS)

Marianne M. Hillemeier, Carol S. Weisman, John J. Botti, Danielle Symons Downs, Mark Feinberg, Gary A. Chase,

Sara A. Baker, Anne-Marie Dyer, and Diana Velott

The Pennsylvania State University

To conduct a randomized trial of a new behavior change intervention – Strong Healthy Women – designed to improve the health and health behaviors of pre- and interconceptional women in low-income rural communities

Research Objectives

Prevalent Risk Factors in CePAWHS

Population-based Survey, Compared with PA and U.S.*(Women ages 18-45, weighted data)

CePAWHS PA U.S.

Obesity (BMI = 30+) 23% 18% 19%Depression/anxiety dx 29% -- 16%Nutritional deficits: Fruit < daily 68% 57% 60% Vegetables < daily 56% 31% 34%Alcohol use (ever) 48% -- 32%Binge drinking (among drinkers) 34% 29% 23%

Smoking 28% 32% 23%Folic acid supplementation 38% 53% 50%

* Comparison data sets include BRFSS 2003, Commonwealth Fund Survey of Women’s Health 1998, National Health Interview Survey 2003

Curriculumdeveloped by teamled by Drs.Mark Feinberg, Prevention ResearchCenterand Danielle Symons Downs,Department of Kinesiology,Pennsylvania StateUniversity

Intervention

Health information &behavior change skills

Intention to changebehavior andself-efficacy

Health behaviorchange

Health statusImprovements

Long-term Outcomes•Unintended pregnancies

•Complications• Preterm birth

• LBW

Intervention Framework and OutcomesRisk Dimension

Behavior Change Goals

Learning Objective

(Example)Behavioral Objective

(Example)

Stress

Manage-ment

Decrease psychosocial stress

Understand causes of stress and behavioral responses

Practice relaxation techniques

Nutrition Increase healthy food choices

Understand nutrition and identify barriers to healthy eating

Eat healthier foods

Physical Activity

Achieve exercise recommendations

Understand guidelines and practice exercises

Exercise regularly

per guidelines

Tobacco/

Alcohol

Decrease tobacco & alcohol use and exposure

Understand impact on pregnancy, triggers, and alternatives

Decrease behaviors and exposures

Gynecolo-gic

Infections

Decrease gynecologic infx

Understand causes and infection

Decrease risk behaviors and seek care

Pregnancy planning

Strategize for pregnancy planning

Understand maternal health and contraception

Discuss plan with provider; use folic acid

Intervention Process

• Six 2-hour sessions over 12-weeks

• Groups facilitated by 2 trained personnel

• Mix of topics at each session• Active learning (discussions, physical activity

sessions, cooking, handouts)

• Goal-setting (“baby steps”)

• Social support (buddy system;

facilitator phone calls)

• Incentives (gift cards, supplies)

A group using core balls

Study Design

Recruitment (n = 692)

Baseline Risk Assessment

Random Assignment

Intervention (12 weeks) Control

Follow-up Risk Assessment

Follow-up telephone surveys at 6 and 12 months;birth records appended

Risk Assessment Content (Behavioral and Biological Markers)

• Questionnaire (health status, health behaviors, psychosocial stress, access to health care, behavioral intent, self-efficacy, etc.)

• Anthropometric measurements (height, weight, BMI, waist circumference)

• Blood pressure

• Non-fasting blood glucose and lipid panel using fingerstick blood

and CardioChek analyzer

Intervention Communities (n = 15)

Eligibility

• Age 18-35 years at enrollment*• Resides in Central PA target area• Not pregnant at enrollment• Capable of becoming pregnant

(no hysterectomy or tubal ligation)• Exclusions: non-English speaking______________________* This age group accounts for > 85% of pregnancies in Central PA

Recruitment MethodsTailored to communities with help of local

Steering Committee members

Active • One-on-one recruitment at social service agencies

(e.g., WIC programs, childcare), schools, and retail settings

Passive• Presentations in social service agencies, schools• Posters and tear-off flyers in businesses, churches,

community centers• Kiosks at local health fairs, farm shows• Inserts in utility bills• Postcards to parents of subsidized child care

Lebanon County Site:Participant Recruitment Sources

25%

9%

12%19%

23%

12%

Utility bill Mailing Insert

Word of Mouth, Other

Social Service Agencies

Subsidized Child Care

Educational Institutions

Retail Establishments

Randomized Trial Enrollees, Compared with Pre- and Interconceptional Women Ages 18-35 in Target Counties

Target

Counties * Enrollees p-value(n = 257) (n = 692)

Poor or near poor a 34% 63% <.0001

Rural b 33% 51% <.0001

Education < college 35% 41% ns

Non-white 3% 9% .003

Unmarried 28% 49% <.0001

No usual source of care 7% 24% <.0001

No health insurance 20% 29% .004

Preconceptional c 37% 43% ns

* CePAWHS surveya Based on federal poverty levelb Based on zipcode-based RUCA codesC Never pregnant

Total Phase II Enrollees

n = 692

Intervention473 (68%)

Control219 (32%)

Did not complete FURA

221 (47%)

CompletedFURA

252 (53%)

CompletedFURA

110 (50%)

Did notComplete FURA

109 (50%)

Base n for pre-post change in biomarkers = 362Telephone interviews

(ongoing)Telephone interviews

(ongoing)

Mean number of sessions attended = 3.90 (14%) 1 – 2 (11%) 3 – 4 (21%) 5 – 6 (54%)

Key Retention IssuesThose who dropped out of the study tended to be younger and to have lower educational levels than those who were retained.

Problem SolutionInadequate inter-session Improve trainingreminder contacts by and supervision ofgroup facilitators group facilitators; use

email and telephone contacts

Lack of reliable childcare Provide on-sitechildcare

Fidelity

Videotaped group sessions were rated for:

– Percent of content delivered in each domain (77% overall; worst for smoking reduction)– Group facilitator performance (e.g., engaging

and involved; confident; provides positive feedback to participants)

– Variation across sites (found only for facilitator performance)

Statistical Analyses

• Intent-to-treat pre-post analyses conducted with analysis of variance

• Baseline measure (pre-test) included as covariate to adjust for differences in baseline measures; follow-up (post-test) measure is the dependent variable

• Used GLM, ordinal logistic regression, or ordinary logistic regression (depending on dependent variable)

• Age and educational attainment controlled to account for potential confounding

Significant Pre-Post Intervention Effects

Intervention Effect P-Value Self-Efficacy For Eating Healthy Food GLM coefficient=1.109 0.018 Perceived Internal Control of Birth Outcomes OR=1.916 0.031 Behavioral Intent To Eat Healthier Foods OR=1.757 0.008 To Be More Physically Active OR=2.185 0.000 Behavior Change Read Food Labels for Nutritional Values OR=2.264 0.001 Meets Recommended Exercise Guidelines OR=1.867 0.019 Daily Use of a Multivitamin With Folic Acid OR=6.595 0.000

NOTE: GLM and logistic regression models also included pre-intervention measurement, age, and educational attainment

Pre-Post Biomarker Assessments

Intervention Effect P-Value Biomarkers GLM coefficient Weight -0.355 0.689 Systolic Blood Pressure -0.655 0.574 Diastolic Blood Pressure 0.213 0.845 Blood Glucose 0.351 0.915 HDL Cholesterol -2.340 0.225 Total Cholesterol -1.540 0.756

NOTE: GLM models also included pre-intervention measurement, age, and educational attainment

Significant Intervention Dose EffectsAmong Intervention Participants

Effect per Additional Session

P-Value

Self-Efficacy Perceived Internal Control of Birth Outcomes OR=1.309 0.002 Behavior Change Read Food Labels for Nutritional Values OR=1.161 0.015 Done Relaxation Exercise or Meditation to Relax OR=1.236 0.009 Daily Use of a Multivitamin With Folic Acid OR=1.448 0.000

NOTE: GLM and logistic regression models also included pre-intervention measurement, age, and educational attainment

Next Steps in Analyses

• Moderation effects (e.g., Did the intervention work better for certain subgroups of women? Did degree of fidelity affect impact?)

• Maintenance of attitudinal and behavior change over the 12-month follow-up period

• Any impact on pregnancy complications or outcomes during follow-up period (~ 115 live births occurred)

Future Research Plans

• Modify the Strong Healthy Women intervention based on Phase II data

• Test the modified intervention in a randomized trial of alternative modes of delivery in a more diverse target population

Acknowledgements

• Funded, in part, by a grant from the Pennsylvania Department of Health

• Collaborating organizations:Pennsylvania State UniversityFamily Health Council of Central PennsylvaniaFranklin & Marshall CollegeLock Haven University of Pennsylvania

• Steering Committee of community representatives