EAL

MNT: Weight Management (2015)

Citation:

Lynch EB, Liebman R, Ventrelle J, Avery EF, Richardson DJ. A self-management intervention for African Americans with comorbid diabetes and hypertension: A pilot randomized controlled trial. Preventing Chronic Disease. 2014; 11: E90.

PubMed ID: 24874782

Study Design:

Randomized Controlled Trial

Class:

A - Click here for explanation of classification scheme.

Quality Rating:

NEUTRAL: See Quality Criteria Checklist below.

Research Purpose:

To determine the effectiveness of an intensive, community-based group intervention that focused on diet, physical activity and peer support for reducing weight among urban-dwelling African Americans with co-morbid T2D and HTN.

Inclusion Criteria:

African American
Aged 18 years or older
Prescribed medication for T2D and HTN
BMI 25kg/m² to 45kg/m²
No medical contraindications to participation.

Exclusion Criteria:

Not described.

Description of Study Protocol:

Recruitment

Through flyers distributed in a federally qualified health center.

Design

RCT
Six-month pilot study.

Intervention

Lifestyle Improvement Through Food and Exercise (LIFE):
- Intensive, group-based T2D self-management class grounded in three theoretical components consistent across cognitive behavioral models of behavior change. Each class (18 x two hours) included:
  - Goal-setting
  - Self-monitoring
  - Motivation
  - Nutrition education and behavioral modification
  - Emotional and social support
  - Role modeling.
- Classes were facilitated by an RDN who was assisted by two African American peer supporters.
Control group: Two three-hour group classless on T2D self-management taught by an African American community health worker.

Statistical Analysis

Proportions were compared between groups using chi-square or Fisher exact tests
T-tests were used for continuous variables
Chi-square were used for categorical variables.

Data Collection Summary:

Timing of Measurements

Baseline and six months.

Dependent Variables

Weight
Height
BMI
HgbA1C
BP
Dietary intake (block FFQ)
Medications
Physical activity (CHAMPS)
Diabetes self-management behavior
Nutrition knowledge
QoL.

Independent Variables

Intervention group vs. control group.

Control Variables

Control group
Timing of measurements.

Description of Actual Data Sample:

Initial N: A total of 183 subjects were screened (61 randomized, 30 intervention, 31 control)
Attrition (final N): N=26 subjects for the intervention group and 29 subjects for the control group
Age: Mean age was 54.1 years
Ethnicity: African American
Other relevant demographics: Of all subjects, 72.2% had an annual income of less than $20,000
Anthropometrics: BP and glucose control in 30% of subjects
Location: Chicago, IL, United States.

Summary of Results:

Key Findings

There was no difference between groups in proportion of participants who lost 5% or more of their body weight. Both groups lost weight but not significantly (-2.8kg LIFE; -1.1kg control). However, a greater proportion of intervention participants achieved reduction in HgbA1C of 0.5% points or more (40% of intervention group vs 21.4% of control group, P=0.03 for difference in proportions).
The intervention group reported significantly greater improvement than control group in performance of diabetes self-management behaviors (number of days following a general diet or specific diet). The intervention group reported significant improvement in exercise behavior from baseline to six months, but no significant difference from the control group (+1,913kcal per week in the LIFE group vs. -603kcal per week in the control group; P<0.10). The intervention group reported a significant greater increase in percentage of kcal from protein than the control group, but no other dietary changes were significant between groups. A significant improvement in nutrition knowledge (+18 patients in LIFE vs. 7.6 patients in control; P<0.0.10).

Author Conclusion:

Compared with short-term group-based T2D self-management education (usual care), a community-based group class featuring appropriately tailored education and strong behavioral support supplemented with individual peer support can lead to a clinically significant reduction in HgbA1C.

Funding Source:

Government:

NIDDK 5R34DK074485

Reviewer Comments:

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?		Yes
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	Yes
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	Yes
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	Yes
	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?	Yes
	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?		N/A
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	N/A
	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.)	N/A
	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?		Yes
	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?	Yes
	6.4.	Was the amount of exposure and, if relevant, subject/patient compliance measured?	Yes
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	Yes
	6.6.	Were extra or unplanned treatments described?	N/A
	6.7.	Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?	Yes
	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?	No
	7.3.	Was the period of follow-up long enough for important outcome(s) to occur?	Yes
	7.4.	Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?	No
	7.5.	Was the measurement of effect at an appropriate level of precision?	No
	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)?	No
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	No
	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?	N/A
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?	Yes
	10.2.	Was the study free from apparent conflict of interest?	Yes