EAL

MNT: Weight Management (2015)

Citation:

Bader A, Gougeon R, Joseph L, Da Costa D, Dasgupta K. Nutritional education through internet-delivered menu plans among adults with type 2 diabetes mellitus: pilot study. JMIR Research Protocols, 2013; 2: e41. PubMed ID: 24185033

Study Design:

Before-After Study

Class:

D - Click here for explanation of classification scheme.

Quality Rating:

POSITIVE: See Quality Criteria Checklist below.

Research Purpose:

To determine the effect of a 24-week internet-based menu-planning program on changes in body weight, blood pressure and glycemia among overweight adults with type 2 diabetes mellitus.

Inclusion Criteria:

Type 2 diabetes mellitus
BMI of 25kg/m² to 45kg/m²
Regular access to a computer and Internet services.

Exclusion Criteria:

History of any significant comorbidities
Taking medications that affect weight
Smoking in the past 12 months
Pregnant or planning to become pregnant within the next 12 months.

Description of Study Protocol:

Recruitment: Potential subjects identified by RDNs working in outpatient clinics
Design: Single-arm intervention study (pre- and post- changes examined)
Blinding used: N/A.

Intervention

Commercially-available Internet-based menu program (SOSCuisine)

Individualized menu plans developed by an SOSCuisine dietitian and delivered using an Internet platform
Participants received weekly menu plans, grocery lists, ingredients' costs with and without grocery store specials and a step-by-step action plan to reduce meal prep time
Detailed nutrition facts for each meal were included.

Statistical Analysis

Descriptive stats at baseline and end-point
Stratified by adherence (defined as having logged in at least once per week for 18 or 24 weeks)
Implausible dietary intake and physical activity values were excluded
Changes and 95% CIs were calculated for change in dependent variables
Linear regression models were used to examine relationships between change in weight and change in blood pressure and glycemic control.

Data Collection Summary:

Timing of Measurements

Assessments completed at baseline and folling intervention (25-26w).

Dependent Variables

body weight
ht
waist circumference
hip circumference
blood pressure
Hgb A1C
Dietary intake via FFQ
Physical activity via IPAQ short form
Stage of change via Weight stages of Change short form

Independent Variables

Adherence to 24w Internet Intervention

Control Variables

Description of Actual Data Sample:

Initial N: 33 (48% female); 15 non-adherent, 18 adherent
Age: 57.8±7.4 years
Ethnicity: Europid.

Anthropometrics

BMI: 34.4±4.5kg/m²
Weight: 95.5±14.3kg.

Location

Montreal, Quebec, Canada.

Summary of Results:

Key Findings

Variables	Mean Change after 24-Week Interveniton	95% CI
Weight	-2.0kg	-2.6 to -1.4
Waist Circumference	-2.2cm	-3.0 to -1.4
Hip Circumference	-2.9cm	-3.6 to -2.1
Hgb A1C	-0.4%	-0.6 to -0.2
SBP	-2.1mmHg	-4.3 to 0.2
DBP	-0.6mmHg	-1.7 to 0.5
Physical Activity, MET-minutes per week	319	-53 to 690
Energy Intake per Day	-418kcal	-518 to -318

Other Findings

On average, participants logged onto the Internet program 14.7 weeks of the 24 weeks
After adjusting for age and sex, the change of one kg unit for a weight (=1% weight change) was associated with an SBP change of -2.2mmHg (95% CI, -3.1 to -0.6) and DBP change of -0.8 (95% CI, -1.4 to -0.1)
There were no clear relationships between changes in CHO intake and change in Hgb A1C or decreased sodium intake and change in blood pressure
AN increase of 100 MET-minutes per week resulted in a -0.2mmHg change (95% CI, -0.3 to-0.1) in SBP and -0.1mmHg (95% CI, -0.1 to -0.02) DBP
Changes in physical activity did not predict weight or Hgb A1C changes.

Author Conclusion:

In adults with type 2 diabetes mellitus, nutrition prescriptions by RDs operationalized through an Internet-delivered menu-planning strategy may improve the cardiovascular risk profile of adherent participants.

Funding Source:

University/Hospital:

Office of Vice Principal, McGill University

Not-for-profit

Diabete Quebec

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?		N/A
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	N/A
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	N/A
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	N/A
	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?	Yes
	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?		N/A
	4.1.	Were follow-up methods described and the same for all groups?	N/A
	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?	N/A
	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?	Yes
	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?	N/A
	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?	Yes
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?	Yes
	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?	Yes
	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)?	N/A
	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?	N/A
	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