Trial Outcomes & Findings for Effectiveness Between Nutritional Counseling Monthly Phone Call Versus Self Help Informative Booklet (NCT NCT01602965)

Results Overview

The measure of weight must be detected with the help of a balance. Weight is measured using Professional Dial Column Scales without shoes or heavy clothing to the nearest 0.1 kg.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

Percent Change in weight loss at one year

Results posted on

2018-09-06

Participant Flow

Participant milestones

Participant milestones
Measure	Counseling Monthly Phone Calls the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviours that need to be changed, problem-solving as to how to make the changes and physical activity levels. Counseling Monthly Phone Calls: the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviors that need to be changed, problem-solving as to how to make the changes and physical activity levels.	Self Help Informative Booklet Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies. Self Help Informative Booklet: Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies
Overall Study STARTED	20	20
Overall Study COMPLETED	16	18
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Counseling Monthly Phone Calls the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviours that need to be changed, problem-solving as to how to make the changes and physical activity levels. Counseling Monthly Phone Calls: the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviors that need to be changed, problem-solving as to how to make the changes and physical activity levels.	Self Help Informative Booklet Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies. Self Help Informative Booklet: Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies
Overall Study Lost to Follow-up	4	2

Baseline Characteristics

Effectiveness Between Nutritional Counseling Monthly Phone Call Versus Self Help Informative Booklet

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Counseling Monthly Phone Calls n=20 Participants the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviours that need to be changed, problem-solving as to how to make the changes and physical activity levels. Counseling Monthly Phone Calls: the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviors that need to be changed, problem-solving as to how to make the changes and physical activity levels.	Self Help Informative Booklet n=20 Participants Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies. Self Help Informative Booklet: Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies	Total n=40 Participants Total of all reporting groups
Age, Continuous	61.6 years STANDARD_DEVIATION 9.08 • n=99 Participants	56.5 years STANDARD_DEVIATION 10.67 • n=107 Participants	59.0 years STANDARD_DEVIATION 9.87 • n=206 Participants
Sex: Female, Male Female	9 Participants n=99 Participants	13 Participants n=107 Participants	22 Participants n=206 Participants
Sex: Female, Male Male	11 Participants n=99 Participants	7 Participants n=107 Participants	18 Participants n=206 Participants
BMI	32.94 kg/m^2 STANDARD_DEVIATION 2.69 • n=99 Participants	32.45 kg/m^2 STANDARD_DEVIATION 2.41 • n=107 Participants	32.69 kg/m^2 STANDARD_DEVIATION 2.55 • n=206 Participants
Weight	96.15 kg STANDARD_DEVIATION 13.81 • n=99 Participants	92.91 kg STANDARD_DEVIATION 9.95 • n=107 Participants	94.53 kg STANDARD_DEVIATION 11.88 • n=206 Participants

PRIMARY outcome

Timeframe: Percent Change in weight loss at one year

The measure of weight must be detected with the help of a balance. Weight is measured using Professional Dial Column Scales without shoes or heavy clothing to the nearest 0.1 kg.

Outcome measures

Outcome measures
Measure	Counseling Monthly Phone Calls n=16 Participants the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviours that need to be changed, problem-solving as to how to make the changes and physical activity levels. Counseling Monthly Phone Calls: the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviors that need to be changed, problem-solving as to how to make the changes and physical activity levels.	Self Help Informative Booklet n=18 Participants Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies. Self Help Informative Booklet: Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies
Weight Loss	7.56 percentage of weight loss Standard Deviation 5.42	2.80 percentage of weight loss Standard Deviation 3.21

Adverse Events

Counseling Monthly Phone Calls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Self Help Informative Booklet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mariela Terrafino

Istituto Ortopedico Rizzoli

Phone: 0516366694

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place