EAL

HD: Effectiveness of Nutrition Intervention Methods (2010)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To describe a faith-based weight-loss intervention for a rural African American community using a community-based participatory research (CBPR) approach.

Inclusion Criteria:

Association with a participating church through membership or participation in a church activity
Age 18 or older
African American
A resident in a southern rural community in North Carolina.

Exclusion Criteria:

Under 18 years of age
Not associated with a local church
Not African American.

Description of Study Protocol:

Recruitment

Announcements at church event by WORD (Wholeness, Oneness, Righteousness, Deliverance) Leaders and the WORD Leadership team
Sign-up sheets at church
Flyers and poster in churches
Word of mouth within community
WORD Health Day held at a participating church to advertise program two weeks prior to start.

Design

Non-randomized intervention
utilized two groups (churches) as unit of assignment and individuals within groups as unity of observation
Four churches enrolled in WORD Program, two assigned to receive intervention, two assigned to control
Controls received intervention after intervention arm of the program was complete
- First control church selected when two intervention churches selected. This church received the intervention one month after the intervention arm of the study was completed.
- Second control church was recruited from a separate community later so that an appropriate number of controls was available. This church did not receive the intervention, they were mailed a health magazine once a month for three months after the intervention arm was completed.

Blinding used

None described

Intervention

Eight-week behaviorally focused weight-loss program
Participants met once per week for two hours in WORD groups (eight to 10 people) led by two trained WORD Leaders (lay health leaders who were trained community members from respective churches)
WORD group meetings included
- One learning module (30 minutes)
- Measurements and mingling (10 minutes)
- Review of previous weeks topic (10 minutes)
- Exercise tape (15 minutes)
- Bible study about health (15 minutes)
- Prayer (five minutes).

Statistical Analysis

Frequencies and T-test conducted for all variables to determine significant differences at baseline between treatment and control groups
Multiple regression used to examine differences between treatment and control group for anthropometric and health-behavior variables from baseline to follow up
Differences in outcome between treatment and control, within treatment and within controls over time were determined
Intent to treat analysis was used.

Data Collection Summary:

Timing of Measurements

Measurements were taken at baseline and at eight-week follow up for all participants

Dependent Variables

Anthropometrics
- Height and weight
- Waist and hip circumference
- BMI
Health-Behavior Variables (via self-administered questionnaire)
- Physical activity: Metabolic equivalent task (MET) hours per week calculated
- Percent calories from fat in diet
- Fruit and vegetable intake
Interviews from WORD Leaders to assess program satisfaction and efficacy.

Independent Variables

Eight- week WORD program

Control Variables

Gender
Ethnicity
Age
Education
Employment
Marital status
Income.

Description of Actual Data Sample:

Initial N: 73 individuals in four churches
- 36 participants in treatment group (two churches)
- 37 participants in control group (two churches)
(Attrition (final N):
61 individuals (84% participation)
- 27 in treatment group
- 34 in control group
Age:
- Mean age was 54.1±13.3 years
- Range 23-83 years
Ethnicity: African American
Other relevant demographics:
- 52/73 were women; 71%
- Majority were employed (70%) and married (60%)
- Mean BMI approximately 37.2
- 48.9%±12.8% calories from fat
- 3.5±2.6 servings per day fruits and vegetables
Differences between groups at baseline:
- BMI: Higher for treatment group
- Education: Higher for control group
- Age: Higher for treatment group
Location: Rural North Carolina.

Summary of Results:

Key Findings

Variables	Treatment Group Mean Change (SE)	Control Group Mean Change (SE)	Treatment-Control Group Mean Change (SE)	Statistical Significance of Group Difference
Weight (pounds)	-3.5 (0.65)	-0.72 (0.69)	-2.8 (0.89)	P=0.003
Hip (cm)	-3.4 (0.86)	-1.1 (0.80)	-2.3 (1.2)	P=0.05
Recreational METs	3.8 (1.7)	-2.6 (1.4)	6.4 (2.2)	P=0.01

Other Findings

Mean change in weight, waist circumference, and hip circumference within treatment group over time was significant after controlling for baseline BMI, education and age, P<0.01
WORD leaders reported program was a success based on follow-up interviews.

Author Conclusion:

Limitations included short time-frame of program and differences between treatment and control group
Suggest follow-up study with longer time frame and larger more representative sample
The CBPR approach facilitated the organization of community representatives to promote health and contributed to program sustainability
A faith-based weight loss program using a CBPR approach is effective in a rural, African American faith community.

Funding Source:

University/Hospital:

University of North Carolina at Chapel Hill, University of Arkansas for Medical Sciences

Reviewer Comments:

Intervention compliance not measured, unclear as to how intervention was tolerated
Other intervening treatments not measured or reported
Disease status not reported, basic medical history would have been useful
Recall bias may have played role in study due to self-administered questionnaire without any accuracy tests.

Quality Criteria Checklist: Primary Research
Relevance Questions
	1.	Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies)	Yes
	2.	Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about?	Yes
	3.	Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice?	Yes
	4.	Is the intervention or procedure feasible? (NA for some epidemiological studies)	Yes

Validity Questions
1.	Was the research question clearly stated?		Yes
	1.1.	Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified?	Yes
	1.2.	Was (were) the outcome(s) [dependent variable(s)] clearly indicated?	Yes
	1.3.	Were the target population and setting specified?	Yes
2.	Was the selection of study subjects/patients free from bias?		Yes
	2.1.	Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study?	Yes
	2.2.	Were criteria applied equally to all study groups?	Yes
	2.3.	Were health, demographics, and other characteristics of subjects described?	Yes
	2.4.	Were the subjects/patients a representative sample of the relevant population?	Yes
3.	Were study groups comparable?		No
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	No
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	No
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	No
	3.4.	If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis?	N/A
	3.5.	If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.)	N/A
	3.6.	If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")?	N/A
4.	Was method of handling withdrawals described?		Yes
	4.1.	Were follow-up methods described and the same for all groups?	Yes
	4.2.	Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.)	Yes
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	Yes
	4.4.	Were reasons for withdrawals similar across groups?	???
	4.5.	If diagnostic test, was decision to perform reference test not dependent on results of test under study?	N/A
5.	Was blinding used to prevent introduction of bias?		No
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	No
	5.2.	Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.)	No
	5.3.	In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?	N/A
	5.4.	In case control study, was case definition explicit and case ascertainment not influenced by exposure status?	N/A
	5.5.	In diagnostic study, were test results blinded to patient history and other test results?	N/A
6.	Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described?		No
	6.1.	In RCT or other intervention trial, were protocols described for all regimens studied?	Yes
	6.2.	In observational study, were interventions, study settings, and clinicians/provider described?	N/A
	6.3.	Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?	No
	6.4.	Was the amount of exposure and, if relevant, subject/patient compliance measured?	No
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	No
	6.6.	Were extra or unplanned treatments described?	No
	6.7.	Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?	N/A
	6.8.	In diagnostic study, were details of test administration and replication sufficient?	N/A
7.	Were outcomes clearly defined and the measurements valid and reliable?		Yes
	7.1.	Were primary and secondary endpoints described and relevant to the question?	Yes
	7.2.	Were nutrition measures appropriate to question and outcomes of concern?	Yes
	7.3.	Was the period of follow-up long enough for important outcome(s) to occur?	No
	7.4.	Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?	Yes
	7.5.	Was the measurement of effect at an appropriate level of precision?	Yes
	7.6.	Were other factors accounted for (measured) that could affect outcomes?	No
	7.7.	Were the measurements conducted consistently across groups?	Yes
8.	Was the statistical analysis appropriate for the study design and type of outcome indicators?		Yes
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	Yes
	8.2.	Were correct statistical tests used and assumptions of test not violated?	Yes
	8.3.	Were statistics reported with levels of significance and/or confidence intervals?	Yes
	8.4.	Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)?	Yes
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	Yes
	8.6.	Was clinical significance as well as statistical significance reported?	Yes
	8.7.	If negative findings, was a power calculation reported to address type 2 error?	No
9.	Are conclusions supported by results with biases and limitations taken into consideration?		Yes
	9.1.	Is there a discussion of findings?	Yes
	9.2.	Are biases and study limitations identified and discussed?	Yes
10.	Is bias due to study's funding or sponsorship unlikely?		Yes
	10.1.	Were sources of funding and investigators' affiliations described?	No
	10.2.	Was the study free from apparent conflict of interest?	Yes