EAL

MNT: Weight Management (2015)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To test a telemedicine system able to promote body weight reduction, nutritional education, and consumption of fresh local produce.

Inclusion Criteria:

Adult patients (>18 years old) with BMI >25kg/m²
Volunteered to follow a specific diet program to be managed with DAI
Adequate familiarity with the use of mobile phones, according to physician's judgment
Possession of personal SIM card.

Exclusion Criteria:

Pregnancy
Diabetes mellitus
Eating disorders
Severe concomitant diseases
Illiteracy or inability to comply with the study requirements.

Description of Study Protocol:

Recruitment

The initiative was publicized in local meetings and on billboards to inform the general population about the chance to use the DAI system to lose weight and receive a specific training on the healthy properties of the Mediterranean diet and the advantages deriving from the consumption of fresh local produce
Three Registered Dietitians operating in diabetes outpatient clinics located in the area of Ascoli Piceno (Marche Region, Italy) were asked to enroll adults in the study.

Design

Multicenter, longitudinal, single-arm, before-and-after study

Blinding used

Implied with measurements

Intervention

The protocol included two face-to-face encounters between participants and dietitians during a 20-week period
DAI (MeTeDa srl, San Benedetto del Tronto, Italy) is software for mobile phones to support patients following a specific dietetic program, which facilitates the communication between the patient and dietitian via short text messages. The DAI system was delivered to participants after an educational session provided by the dietitian and lasting up to two hours.
All enrolled patients were involved in a weight loss and nutritional education program, including the following components:
- Customized diet intervention: Each patient received a personalized nutritional plan aiming to achieve a specific weight target and to increase knowledge of a correct nutritional regime. The plan was elaborated by the dietitians for each participant according to his or her individual characteristics.
- DAI system: Allowed a continuous consultation of the diet program on the mobile phone and supported patients in the daily management of food intake. The data recorded were sent via SMS to the dietitian every one to three weeks. Dietitians reviewed the data on their PC and replied from their PC to the patient's mobile phone via SMS, confirming or modifying the dietary program or giving useful suggestions.
- Proactive call center: Participants received weekly proactive telephone calls provided by a trained operator aiming to reinforce some fundamental concepts about correct nutrition and physical activity. The operators of the proactive call centers were instructed on the use of standardized materials to explain some main concepts about the benefits of physical activity on clinical outcomes.

Statistical Analysis

Assuming a SD of baseline body weight of 12.0kg, it was estimated that a sample of 128 individuals would be needed to detect a change of 3.0kg in body weight from baseline to end of study with a power of 80% (alpha=0.05). Assuming a dropout rate of 10%, the required sample was 140 individuals.
Baseline clinical data were expressed as mean and SD or frequencies
Additional information on the use of the system was expressed as median and range or frequencies
Pre-post changes in the mean levels of clinical and nutritional parameters were expressed as means and 95% confidence intervals
Baseline and end-of-study levels were compared using the Wilcoxon test
The McNemar test was used to compare variation in the categorical variables.

Data Collection Summary:

Timing of Measurements

Measurements made at baseline and after 20 weeks.

Dependent Variables

Body weight
Waist circumference
BMI
Fasting blood glucose
Lipid profile
Food habits, mean daily macronutrient content and variation of the mean daily fiber intake (overall and from fresh local produce)
Percentage of patients reaching the correct mean daily distribution of the macronutrients for the "Mediterranean diet target"
Physical activity
Satisfaction with DAI system assessed through 13-item questionnaire.

Independent Variables

The protocol included two face-to-face encounters between participants and dietitians during a 20-week period; all enrolled patients were involved in a weight loss and nutritional education program
DAI (MeTeDa srl, San Benedetto del Tronto, Italy) is software for mobile phones to support patients following a specific dietetic program, which facilitates the communication between the patient and dietitian via short text messages. The DAI system was delivered to participants after an educational session provided by the dietitian and lasting up to two hours.

Control Variables

Sociodemographic data on age, gender, highest level of completed school education, comorbidities and pharmacologic therapies.

Description of Actual Data Sample:

Initial N: 140 consecutive patients enrolled
Attrition (final N): 115 completed the follow-up, 58.3% female, 41.7% male. Compared with completers, patients who dropped out were more often female and had a significantly higher daily calorie intake compared with patients who completed the follow-up.
Age: Mean age 42.9±12.2 years
Ethnicity: Not reported
Other relevant demographics:
Anthropometrics: Mean BMI 31.1±4.4kg/m²
Location: Italy.

Summary of Results:

Key Findings

Participants regularly communicated with dietitians through short text messages. The median (range) number of text messages sent by each patient during the study was 35, equaling one of two text messages per week.
The dietitians sent a median (range) number of six text messages to transmit the diet program to the DAI and 29 messages with suggestions, comments, and prescription modifications per patient.
The diet program promoted by DAI was effective in terms of nutritional education: Total calorie intake was reduced by approximately 300kcal.
There was also an increase in the level of physical activity in over one out of four participants
Mean reduction in body weight was -2.5 (95% confidence interval: -3.2 to -1.8) kg, whereas the reduction in waist circumference was -3.7 (95% confidence interval: -4.6 to -2.9) cm and in BMI was 1.0 (95% confidence interval: -0.7 to -1.2) kg/m².
The software was useful as an educational tool: Participants achieving the Mediterranean diet targets increased from 14.4% to 69.8% after 20 weeks
On average, each patient recognized and chose fresh local vegetables eight times per week during the follow-up
The intervention did not produce any relevant pre-post modifications in the laboratory parameters
The patients' satisfaction with the DAI system documented the overall DAI was judged as "excellent" or "good" by 95% of the patients, 70% of participants were "extremely" or "very satisfied" with its use, the system was defined as "extremely useful" or "very useful" in the dietary program management by 65% of enrolled subjects and 76% were "definitely" or "probably interested" in purchasing it.
Furthermore, 76 of the sample declared that DAI increased "very much" or "much" their understanding of the qualitative and quantitative content of food, 46% stated that DAI increased their knowledge of the relationship between food and territory, and 41% stated that DAI promoted the seeking and purchase of local produce; the satisfaction was particularly high in subjects who had lost 5kg or more.
The most appreciated qualities of the software were the constant support, the flexibility of the diet, the chance of not using the balance, and the easy and constant communication with the dietitian. Among the limitations, patients pointed out the time required to record food eaten, the lack of some food in the atlas, and the technical difficulty of deleting mistaken data.
The median number of text messages sent by each patient during the study was 35, equaling one or two text messages per week, and the dietitians sent a median of six text messages to transmit the diet program to the interactive diary and 29 messages with suggestions, comments, and prescription modifications per patient. In terms of costs, assuming a cost of 15 Euro cents per message and considering that each participant sent an average of 35 text messages, the overall cost sustained did not exceed four Euros.

Comparison Between Baseline and End-of-Study Participant Characteristics

Variables	Baseline	Changes at Follow-up	P value
Body weight (kg)	83.3±14.8	-2.5 (-3.2, -1.8)	<0.0001
BMI (kg/m²)	31.1±4.4	-1 (-1.2, -0.7)	<0.0001
Waist circumference (cm)	99±11.8	-3.7 (-4.6, -2.9)	<0.0001
Light physical activity (percent)	97.6%	70.0%	<0.0001
Moderate/intense physical activity (percent)	2.4%	30.0%	<0.0001
Mediterranean diet goals (percent)	14.4%	69.8%	<0.0001
Calories (kcal)	1,783±480	-287.4 (-365.2, -209.5)	<0.0001
Total carbohydrates (g)	231±78	-37.1 (-50.8, -23.4)	<0.0001
Simple carbohydrates (g)	71±25	-3.7 (-8.4, 1.1)	0.12
Lipids (g)	68±25	-14.9 (-19.2, -10.6)	<0.0001
Cholesterol (mg)	177±82	-12.7 (-28.1, 2.7)	0.02
Proteins (g)	79±58	-10.5 (-21, 0)	0.02
Alcohol (g)	3±8	-0.7 (-2, 0.6)	0.18
Sodium (mg)	1,383±692	-195.1 (-330.2, -60)	0.003
Total fiber (g)	24±8	0.4 (-0.9, 1.7)	0.49
Fiber in 1,000 kcals (percent)	14±5	2.4 (1.5, 3.2)	<0.0001

Author Conclusion:

In conclusion, the results of this pilot study enabled the clarification of the potential of an innovative information technology and telemedicine system to support people needing to reduce their body weight. The tool was also suitable for a more articulated initiative of "nutritional education" aiming to promote the healthy properties of the Mediterranean diet and the consumption of fresh local produce. The promising results of this pilot study will be used to design a controlled randomized trial to provide more robust evidence on the efficacy of the DAI.

Funding Source:

Government:

Government of the Marche Region, Italy

Reviewer Comments:

Compared with completers, patients who dropped out were more often female and had a significantly higher daily calorie intake compared with patients who completed the follow-up. The authors note that this confirms poor compliance and difficulty in reaching beneficial and durable results, especially in patients with less motivation and higher levels of excess weight and obesity. Authors note the following limitations:

This was a pilot study to test the feasibility and acceptability of the system; the lack of a control group did not allow the comparison of results obtained using DAI with those obtained using standardized approaches or other experimental interventions.
The short follow-up did not allow assessment of the durability of the weight loss/nutrition education or detection of the relevant modifications in the laboratory parameters.

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?	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?	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?		Yes
	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.)	Yes
	5.3.	In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?	Yes
	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?	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?	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?	N/A
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)?	???
	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?	Yes
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